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PT. DENTSPLY SIRONA INDONESIA

Authorized Representative in Indonesia

Gedung Tempo Scan Tower, Lantai 28, Jl. H.R. Rasuna Said Kav. 3-4
194 Products Represented
50 Manufacturers
Total Products
194
Manufacturers
50
Product Classes
2
Risk Classes
3
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
87 products
44.8%
Kelas Resiko : B
78 products
40.2%
Kelas Resiko : C
29 products
14.9%
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (194)
Complete portfolio registered with BPOM

PRIMEPRINT Guide

Manufacturer:

DETAX GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 12, 2025

DENTSPLY SIRONA Dental Treatment Unit

Manufacturer:

SIRONA DENTAL SYSTEMS GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 6, 2025

ANTAEOS Root Filler 'L"

Manufacturer:

MAILLEFER INSTRUMENTS HOLDING SàRL

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 29, 2024

DENTSPLY SIRONA Universal Stain & Overglaze

Manufacturer:

DS REP B.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 6, 2024

CERAMCO 3

Manufacturer:

DS REP B.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 4, 2024

DENTSPLY MAILLEFER Unimetric Set

Manufacturer:

MAILLEFER INSTRUMENTS HOLDING S.A.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 17, 2024

DENTSPLY Propex Pixi Apex Locator

Manufacturer:

MAILLEFER INSTRUMENTS HOLDING SARL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 13, 2024

CELTRA PRESS

Manufacturer:

DEGUDENT GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 9, 2024

DENTSPLY Maillefer Transmetal

Manufacturer:

MAILLEFER INSTRUMENT HOLDING SARL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 7, 2024

DENTSPLY Radix Anker Standard

Manufacturer:

MAILLEFER INSTRUMENTS HOLDING SARL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 7, 2024

KENDO Hedstroem Files CC-CORD

Manufacturer:

VDW GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 17, 2024

ANTAEOS K-File CC-CORD

Manufacturer:

VDW GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 17, 2024

KENDO K-Reamer CC-CORD

Manufacturer:

VDW GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 13, 2024

MTWO Gutta Percha

Manufacturer:

DENTSPLY INDÚSTRIA E COMÉRCIO LTDA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 6, 2024

SPIRO COLORINOX

Manufacturer:

MAILLEFER INSTRUMENT HOLDING SARL

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 30, 2024

ASTRA TECH Implant System ™ Dental Instruments

Manufacturer:

DENTSPLY IMPLANTS MANUFACTURING GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 19, 2024

DENTSPLY Mailllefer Endo Z

Manufacturer:

MAILLEFER INSTRUMENT HOLDING S.A.R.L.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 19, 2024

C-PILOT CC+ Endodontic Instrument

Manufacturer:

VDW GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 15, 2024

DENTSPLY CAULK Integrity Temporary Crown & Bridge Material

Manufacturer:

DENTSPLY CAULK.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 13, 2024

MTWO Endodontic Instrument

Manufacturer:

MAILLEFER INSTRUMENTS HOLDING SàRL

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 4, 2024

NEO SPECTRA ™ ST Flow

Manufacturer:

DENTSPLY DETREY GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 31, 2024

RECIPROC Endodontic Instrument

Manufacturer:

MAILLEFER INSTRUMENTS HOLDING SàRL

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 28, 2024

R-PILOT Endodontic Instrument

Manufacturer:

MAILLEFER INSTRUMENTS HOLDING SàRL

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 25, 2024

NEO SPECTRA™ ST

Manufacturer:

DENTSPLY DETREY GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 5, 2024

PROTAPER Universal

Manufacturer:

MAILLEFER INSTRUMENTS HOLDING SARL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 27, 2024

AXEOS X-ray System

Manufacturer:

SIRONA DENTAL SYSTEMS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 13, 2024

PRO ROOT MTA

Manufacturer:

DENTSPLY TULSA DENTAL SPECIALTIES

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 21, 2024

DENTSPLY MAILLEFER ZEKRYA Extra Long Tapered

Manufacturer:

MAILLEFER INSTRUMENTS HOLDING SARL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 14, 2024

SIRONA InEos X5 Extraoral Scanner

Manufacturer:

SIRONA DENTAL SYSTEMS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 25, 2024

SIRONA inLab MC X5

Manufacturer:

SIRONA DENTAL SYSTEMS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 23, 2024

CONNECT SW

Manufacturer:

SIRONA DENTAL SYSTEMS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 25, 2024

SICAT Implant Planning

Manufacturer:

SICAT GMBH & CO. KG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 22, 2024

CEREC SW

Manufacturer:

SIRONA DENTAL SYSTEMS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 19, 2024

SIDEXIS 4

Manufacturer:

SIRONA DENTAL SYSTEMS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 17, 2024

PRIMESCAN AND

Manufacturer:

SIRONA DENTAL SYSTEMS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 12, 2024

DAC Universal

Manufacturer:

SIRONA DENTAL SYSTEMS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2024

T2 Turbines and Handpieces

Manufacturer:

SIRONA DENTAL SYSTEMS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 27, 2024

SMARTLITE PRO ENDOACTIVATOR™

Manufacturer:

DENTSPLY LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 12, 2024

ANKYLOS Drills

Manufacturer:

DENTSPLY IMPLANTS MANUFACTURING GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 20, 2023

ANKYLOS Dental Implants

Manufacturer:

DENTSPLY IMPLANTS MANUFACTURING GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 19, 2023

ANKYLOS Surgical Instruments

Manufacturer:

DENTSPLY IMPLANTS MANUFACTURING GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 18, 2023

ANKYLOS Abutments

Manufacturer:

DENTSPLY IMPLANTS MANUFACTURING GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 14, 2023

ANKYLOS Prosthetic Instruments

Manufacturer:

DENTSPLY IMPLANTS MANUFACTURING GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 11, 2023

JELTRATE

Manufacturer:

DENTSPLY DENTAL (TIANJIN) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 24, 2023

DENTOSEPT Clean

Manufacturer:

ALPRO MEDICAL GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 14, 2023

ASTRA TECH Implant System Screw Retained Abutments

Manufacturer:

DENTSPLY IMPLANTS MANUFACTURING GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 13, 2023

ASTRA TECH Implant System Cement Retained Abutments

Manufacturer:

DENTSPLY IMPLANTS MANUFACTURING GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 13, 2023

ASTRA TECH Implant System

Manufacturer:

DENTSPLY IMPLANTS MANUFACTURING GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 6, 2023

ASTRA TECH Implant System Cover Screw and Healing Components

Manufacturer:

DENTSPLY IMPLANTS MANUFACTURING GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 2, 2023

ASTRA TECH Implant System Overdenture and Acuris Abutments

Manufacturer:

DENTSPLY IMPLANTS MANUFACTURING GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 2, 2023

ASTRA TECH Implant System

Manufacturer:

DENTSPLY IMPLANTS MANUFACTURING GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 31, 2023

DENTSPLY DETREY Poly -F Intro

Manufacturer:

DENTSPLY DETREY GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 30, 2023

PRIME & BOND UNIVERSAL

Manufacturer:

DENTSPLY DETREY GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 27, 2023

DENTSPLY Esthet - X Flow Liquid Micro Hybrid

Manufacturer:

DENTSPLY CAULK

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2023

DENTSPLY POLY F Plus

Manufacturer:

DENTSPLY DETREY GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2023

PRORINSE

Manufacturer:

MAILLEFER INSTRUMENT HOLDING SARL.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 20, 2023

DENTSPLY The Palodent System

Manufacturer:

DENTSPLY CAULK

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 17, 2023

DENTSPLY Maillefer Paper Points for ProTaper

Manufacturer:

MAILLEFER INSTRUMENT HOLDING SARL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 17, 2023

SMARTLITE PRO Modular LED Curing Light

Manufacturer:

I-DENT INNOVATIONS FOR DENTISTRY SA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 16, 2023

DENTSPLY Automatrix Retainerless Matrix System

Manufacturer:

DENTSPLY CAULK

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 16, 2023

DENTSPLY MAILLEFER Lentulo Paste Carrier

Manufacturer:

MAILLEFER INSTRUMENT HOLDING SARL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 14, 2023

AH Canal Sealing and Filling Materials

Manufacturer:

DENTSPLY DETREY GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 11, 2023

DENTSPLY MAILLEFER Gates Glidden Dril

Manufacturer:

MAILLEFER INSTRUMENT HOLDING SARL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 10, 2023

WAVEONE GOLD Reciprocating File Sterile

Manufacturer:

MAILLEFER INSTRUMENTS HOLDING SARL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 10, 2023

TRUNATOMY ™ Absorbent Points

Manufacturer:

MAILLEFER INSTRUMENTS HOLDING SARL

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 9, 2023

DENTSPLY Detrey Conditioner 36

Manufacturer:

DENTSPLY DETREY GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 9, 2023

PROTAPER Next Conform Fit ™ Gutta-Percha

Manufacturer:

MAILLEFER INSTRUMENTS HOLDING SARL

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 6, 2023

DENTSPLY MAILLEFER Endo Access Bur

Manufacturer:

MAILLEFER INSTRUMENT HOLDING SARL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 6, 2023

DENTSPLY MAILLEFER Diamendo

Manufacturer:

MAILLEFER INSTRUMENTS HOLDING SARL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 5, 2023

DENTSPLY M-Access K-File

Manufacturer:

MAILLEFER INSTRUMENTS HOLDING SARL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 5, 2023

SPECTRUM Bond

Manufacturer:

DENTSPLY DETREY GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 5, 2023

DENTSPLY M-Access K-Reamers

Manufacturer:

MAILLEFER INSTRUMENTS HOLDING S.A.R.L.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 4, 2023

DENTSPLY Wide Maillefer

Manufacturer:

MAILLEFER INSTRUMENT HOLDING SARL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 4, 2023

K- FILE READY STEEL

Manufacturer:

MAILLEFER INSTRUMENT HOLDING SARL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 4, 2023

FLUOROCORE2+

Manufacturer:

DENTSPLY CAULK

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 26, 2023

PALODENT 360 Circumferential Matrix System

Manufacturer:

DENTSPLY LLC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 21, 2023

DENTSPLY Applicator Tips

Manufacturer:

DENTSPLY DETREY GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 21, 2023

SURESMILE Aligner

Manufacturer:

ORAMETRIX

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 20, 2023

DYRACT XP

Manufacturer:

DENTSPLY DETREY GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 20, 2023

DENTSPLY X - Smart

Manufacturer:

MAILLEFER INSTRUMENT HOLDING SARL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 15, 2023

PALODENT V3 Sectional Matrix System

Manufacturer:

DENTSPLY CAULK

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 15, 2023

DYRACT FLOW

Manufacturer:

DENTSPLY DETREY GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 14, 2023

WAVEONE Gold Gutta Percha Points

Manufacturer:

DENTSPLY TULSA DENTAL SPECIALTIES

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 13, 2023

AH More

Manufacturer:

DENTSPLY DETREY GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 13, 2023

DETREY Zinc

Manufacturer:

DENTSPLY DETREY GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 12, 2023

DENTSPLY Chemfil Superior

Manufacturer:

DENTSPLY DETREY GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 11, 2023

TruNatomy ™ Irrigation Needle

Manufacturer:

DENTAL PRODUCTS LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 11, 2023

TRUNATOMY™ Conform Fit Gutta-Percha

Manufacturer:

MAILLEFER INSTRUMENTS HOLDING SARL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 11, 2023

PROTAPER GOLD Conform Fit ™ Gutta-Percha

Manufacturer:

MAILLEFER INSTRUMENTS HOLDING SARL

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 11, 2023

DENTSPLY Propex II

Manufacturer:

MAILLEFER INSTRUMENT HOLDING SARL.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 11, 2023

WAVEONE Gold Paper Points

Manufacturer:

DENTSPLY TULSA DENTAL SPECIALTIES

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 5, 2023

DYCAL Radiopaque Calcium Hydroxide Composition Dentin

Manufacturer:

DENTSPLY CAULK

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 5, 2023

GUYS-SMART ™

Manufacturer:

ASEPTICO INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 2, 2023

AQUASIL ULTRA+ Smart Wetting Impression Material

Manufacturer:

DENTSPLY CAULK

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 31, 2023

KALZINOL

Manufacturer:

DENTSPLY DETREY GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 29, 2023

PROTAPER Ultimate Shaping Files & Kit

Manufacturer:

MAILLEFER INSTRUMENTS HOLDING SARL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 29, 2023

AQUASIL ULTRA+ Smart Wetting Impression Material

Manufacturer:

DENTSPLY CAULK

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 28, 2023

IRM Standard Package - Ivory

Manufacturer:

DENTSPLY CAULK

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 28, 2023

AH PLUS Bioceramic Sealer

Manufacturer:

MARUCHI

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 11, 2023

PROTAPER ULTIMATE ™ Solution Kit

Manufacturer:

MAILLEFER INSTRUMENTS HOLDING SàRL

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 27, 2023

SIRONA XIOS XG Supreme

Manufacturer:

SIRONA DENTAL, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 7, 2023

SIRONA DENTAL Dental Treatment Units

Manufacturer:

SIRONA DENTAL SYSTEMS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 8, 2023

DENTSPLY SIRONA Dental Treatment Units

Manufacturer:

SIRONA DENTAL SYSTEMS GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 4, 2023

DENTSPLY SIRONA Dental Treatment Units

Manufacturer:

SIRONA DENTAL SYSTEMS GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 17, 2023

T3 LINE Contra Angle Handpiece

Manufacturer:

SIRONA DENTAL SYSTEMS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 3, 2023

PROTAPER Gold Paper Points

Manufacturer:

DENTSPLY TULSA DENTAL SPECIALTIES

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 15, 2023

PRISMA GLOSS

Manufacturer:

DENTSPLY CAULK

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 10, 2023

SELF CURE ACTIVATOR

Manufacturer:

DENTSPLY CAULK.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 10, 2023

DENTSPLY Uniclip Set

Manufacturer:

MAILLEFER INSTRUMENT HOLDING S.A.R.L.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 7, 2023

PROTAPER NEXT Paper Points

Manufacturer:

MAILLEFER INSTRUMENTS HOLDING SARL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 7, 2023

TRUNATOMY ™ Endodontic Files

Manufacturer:

MAILLEFER INSTRUMENTS HOLDING SARL

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 6, 2023

PROGLIDER

Manufacturer:

MAILLEFER INSTRUMENTS HOLDING SARL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 3, 2023

VERIFIER

Manufacturer:

MAILLEFER INSTRUMENTS HOLDING SA.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 3, 2023

SUREFIL High Density Posterior Restorative

Manufacturer:

DENTSPLY CAULK

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 2, 2023

DENTSPLY REGISIL Rigid Vinyl Polysiloxane Bite Reg

Manufacturer:

DENTSPLY CAULK

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 2, 2023

DENTSPLY MAILLEFER Cavity Z Access

Manufacturer:

MAILLEFER INSTRUMENTS HOLDING SARL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 28, 2023

DENTSPLY SmartLite Focus

Manufacturer:

DENTSPLY DETREY GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 27, 2023

SPECTRUM TPH 3

Manufacturer:

DENTSPLY DETREY GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 26, 2023

DENTSPLY Micro Opener

Manufacturer:

MAILLEFER INSTRUMENTS HOLDING SARL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 24, 2023

DENTSPLY PATHFILE

Manufacturer:

MAILLEFER INSTRUMENTS HOLDING SARL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 20, 2023

DENTSPLY MAILLEFER K - File Nitiflex

Manufacturer:

MAILLEFER INSTRUMENT HOLDING SARL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 16, 2023

DENTSPLY CAULK Calibra Esthetic Resin Cement

Manufacturer:

DENTSPLY CAULK.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 13, 2023

DENTSPLY Maillefer Finger Spreader

Manufacturer:

MAILLEFER INSTRUMENT HOLDING SARL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 25, 2023

DENTSPLY ProTaper Gutta Percha Points

Manufacturer:

DENTSPLY INDUSTRIA E COMERCIO LTDA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 28, 2022

DENTSPLY M-Access Hedstroems

Manufacturer:

MAILLEFER INSTRUMENT HOLDING SARL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 24, 2022

ENHANCE POGO Polishing System

Manufacturer:

DENTSPLY CAULK

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 17, 2022

ACRYLIC TEETH - VIPI DENT PLUS

Manufacturer:

VIPI INDUSTRIA, COMERCIA EXPORTACAO E IMPORTACAO DE PRODUTOS ODONTOLOGICOS LTDA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 17, 2022

SDR Plus

Manufacturer:

DENTSPLY CAULK

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 16, 2022

DENTSPLY Enhance Finishers

Manufacturer:

DENTSPLY CAULK

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 8, 2022

VIPI CRIL PLUS

Manufacturer:

VIPI INDUSTRIA ,COMERCIA EXPORTACAO E IMPORTACAO DE PRODUTOS ODONTOLOGICOS LTDA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 24, 2022

DENTSPLY MAILLEFER Glyde File Prep

Manufacturer:

DENTSPLY CAULK

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 5, 2022

DENTSPLY Aquasil Ultra XLV Fast Set

Manufacturer:

DENTSPLY CAULK.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 12, 2022

HELIODENT More

Manufacturer:

SIRONA DENTAL SYSTEMS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 16, 2022

TROPICALGIN

Manufacturer:

ZHERMACK S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 4, 2022

HYDROGUM Soft

Manufacturer:

ZHERMACK S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 28, 2022

HYDROGUM 5

Manufacturer:

ZHERMACK S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 24, 2022

ELITE P&P

Manufacturer:

ZHERMACK S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 21, 2022

ZETAPLUS

Manufacturer:

ZHERMACK S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 11, 2022

DENTSPLY MAILLEFER Spreader A

Manufacturer:

MAILLEFER INSTRUMENTS HOLDING SARL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 22, 2022

M- ACCESS K-FLEXOFILE

Manufacturer:

MAILLEFER INSTRUMENTS HOLDING S.A.R.L.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 22, 2022

SENSEUS PROFINDER READY STEEL

Manufacturer:

MAILLEFER INSTRUMENTS HOLDING SARL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 19, 2022

WAVEONE Gold Glider

Manufacturer:

MAILLEFER INTRUMENTS HOLDING S.A.R.L.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 10, 2022

GUTTA CORE Obturator

Manufacturer:

DENTSPLY TULSA DENTAL SPECIALTIES.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 10, 2022

PROTAPER Gold Files

Manufacturer:

MAILLEFER INTRUMENTS HOLDING SARL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 27, 2022

DENTSPLY Protaper Next

Manufacturer:

MAILLEFER INSTRUMENTS HOLDING SARL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 11, 2022

C + FILE Ready Steel

Manufacturer:

MAILLEFER INSTRUMENTS HOLDING S.A.R.L.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 5, 2022

PLUGGER Obturation Instrument

Manufacturer:

MAILLEFER INSTRUMENT HOLDING S.A.R.L.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 5, 2022

K - FLEXOFILE Ready Steel

Manufacturer:

MAILLEFER INSTRUMENTS HOLDING S.A.R.L.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 5, 2022

START - X Ultrasonic Instrument

Manufacturer:

MAILLEFER INSTRUMENT HOLDING S.A.R.L.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 30, 2022

DENTSPLY MAILLEFER RADIX Fiber Post Basic Kit

Manufacturer:

MAILLEFER INSTRUMENT HOLDING SARL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 29, 2022

VIPI FLASH

Manufacturer:

VIPI INDUSTRIA ,COMERCIA EXPORTACAO E IMPORTACAO DE PRODUTOS ODONTOLOGICOS LTDA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 15, 2022

DENTSPLY X - SMART PLUS Endomotor

Manufacturer:

MAILLEFER INSTRUMENTS HOLDING S.A.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 8, 2022

PROTAPER Ultimate Conform Fit Gutta-Percha Points

Manufacturer:

DENTSPLY TULSA DENTAL SPECIALTIES

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 29, 2021

INTEGO Treatment Center

Manufacturer:

SIRONA DENTAL SYSTEM GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 2, 2021

DENTSPLY Ceram - X Duo

Manufacturer:

DENTSPLY DETREY GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 25, 2021

CELTRA

Manufacturer:

DEGUDENT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 15, 2021

DENTSPLY Aquasil Soft Putty/Regular Set

Manufacturer:

DENTSPLY DETREY ,GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 11, 2021

DENTSPLY Aquasil Ultra LV Fast Set

Manufacturer:

DENTSPLY CAULK.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 29, 2021

DENTSPLY Aquasil Ultra XLV

Manufacturer:

DENTSPLY CAULK.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 29, 2021

DENTSPLY Aquasil Monophase

Manufacturer:

DENTSPLY CAULK.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 22, 2021

DENTSPLY Regisil 2X

Manufacturer:

DENTSPLY CAULK

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 22, 2021

SMARTCEM 2 Self Adhesive Cement

Manufacturer:

DENTSPLY CAULK

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 21, 2021

LUCITONE HIPA

Manufacturer:

DENTSPLY SIRONA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 5, 2021

T1 LINE - Contra Angles And Straight Hand Piece

Manufacturer:

SIRONA DENTAL SYSTEM GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 3, 2021

ASTRA TECH Implant System

Manufacturer:

DENTSPLY IMPLANTS MANUFACTURING GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 13, 2021

ORTHOPHOS S 2D

Manufacturer:

SIRONA DENTAL SYSTEMS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 18, 2021

ORTHOPHOS SL 2D

Manufacturer:

SIRONA DENTAL SYSTEMS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 18, 2021

ASTRA TECH Implant System Direct Abutment™ EV

Manufacturer:

DENTSPLY IMPLANTS MANUFACTURING GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 17, 2020

MIS Dental Instruments

Manufacturer:

MIS IMPLANTS TECHNOLOGIES LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 21, 2020

MIS Seven Abutments

Manufacturer:

MIS IMPLANTS TECHNOLOGIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 6, 2020

MIS SEVEN Dental Implants

Manufacturer:

MIS IMPLANTS TECHNOLOGIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 25, 2020

MIS C1 Dental Implants

Manufacturer:

MIS IMPLANTS TECHNOLOGIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 30, 2020

PROPEX IQ Apex Locator

Manufacturer:

MAILLEFER INSTRUMENTS HOLDING SARL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 30, 2020

SOFSCALE Calculus Scaling Gel

Manufacturer:

DENTSPLY PROFESSIONAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 6, 2020

DENTSPLY Cavitron Jet Plus

Manufacturer:

DENTSPLY PROFESSIONAL.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 6, 2020

DENTSPLY Professional Cavitron Jet - Fresh Powder

Manufacturer:

DENTSPLY LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 21, 2020

DENTSPLY Cavitron BobCat Pro Ultrasonic Scaler

Manufacturer:

DENTSPLY PROFESSIONAL.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 21, 2020

DENTSPLY Cavitron Plus Ultrasonic Scaler

Manufacturer:

DENTSPLY PROFESSIONAL.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 21, 2020

DENTSPLY XCP DS Fit Universal Sensor Holder

Manufacturer:

DENTSPLY RINN.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 12, 2020

DENTSPLY Cavitron Insert

Manufacturer:

DENTSPLY PROFESSIONAL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 12, 2020

FASTIPS Disposable Air-Water Syringe Tips

Manufacturer:

DENTSPLY PROFESSIONAL

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 10, 2020

DENTSPLY MAILEFER Guys Percha Plugs

Manufacturer:

MAILLEFER INSTRUMENT HOLDING SARL

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 21, 2020

DENTSPLY Maillefer Finger Plugger

Manufacturer:

MAILLEFER INSTRUMENT HOLDING SARL

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 21, 2020

DENTSPLY Maillefer Miller Broach

Manufacturer:

MAILLEFER INSTRUMENT HOLDING SARL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 27, 2019

DENTSPLY X-SMART IQ Endodontic Handpiece Set

Manufacturer:

MAILLEFER INSTRUMENTS HOLDING SARL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 27, 2019

CERCON Base

Manufacturer:

DEGUDENT GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2019

CERAMCO 3

Manufacturer:

DENTSPLY CERAMCO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 6, 2019

DENTSPLY CAULK Aquasil LV

Manufacturer:

DENTSPLY CAULK

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 6, 2019

DENTSPLY SDR SMART DENTIN REPLACEMENT

Manufacturer:

DENTSPLY DETREY GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 29, 2019

CELTRA Universal

Manufacturer:

DENTSPLY CERAMCO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 29, 2019

CERAM. X SPHERE TEC ONE SYRINGE

Manufacturer:

DENTSPLY DETREY GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 11, 2019

NRC Non Rinse Conditioner

Manufacturer:

DENTSPLY DETREY GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 1, 2019

PRIME & BOND One Etch & Rinse

Manufacturer:

DENTSPLY DETREY GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 28, 2019

OMNICAM AM

Manufacturer:

SIRONA DENTAL SYSTEMS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2019

Data sourced from BPOM (Badan Pengawas Obat dan Makanan), Indonesia.

Last updated: December 2025