HSA · registration DE0019521

Nobel Biocare Nobel Zygoma

Name: Nobel Biocare Nobel Zygoma — HSA DE0019521
Creator: Nobel Biocare AB
Keywords: Nobel Biocare Nobel Zygoma, Nobel Biocare Nobel Zygoma, DE0019521, Dental, HSA

SingaporeDentalClass CNobel Biocare AB

Verified

Official record identity

Registration number: DE0019521
Model name: Connection to Handpiece; Implant Driver Bmk Syst RP 21 mm; Implant Driver Bmk Syst RP 26 mm; Implant Driver Bmk Syst RP 34 mm; Healing Abutment Bmk Syst RP Ø5x3 mm; Healing Abutment Bmk Syst RP Ø5x5 mm; Screwdriver Manual UniGrip 28 mm; Screwdriver Machine UniGrip 25 mm; Zygoma Surgical Kit; Bmk Syst Zygoma 17° Multi-unit Abut 2mm; Bmk Syst Zygoma 17° Multi-unit Abut 3mm; Bmk Syst Zygoma Multi-unit Abut 3mm; Bmk Syst Zygoma Multi-unit Abut 5mm; Bmk Syst Zygoma Healing Abutment Ø4x3mm; Bmk Syst Zygoma Healing Abutment Ø4x5mm; Bmk Syst Zygoma Implant Cover Screw; Bmk Syst Zygoma Twist Drill 2.9 mm; Bmk Syst Zygoma Twist Drill 2.9 mm short; Bmk Syst Zygoma Pilot Drill 3.5 mm; Bmk Syst Zygoma Twist Drill 3.5 mm; Bmk Syst Zygoma Twist Drill 3.5 mm short; Bmk Syst Zygoma Pilot Drill 3.5 mm short; Bmk Syst Zyg Impr Cop Open Tray Ø4mm; Bmk Syst Zygoma Abutment Screw; Bmk Syst Zygoma Healing Abutment Ø4x3mm; Bmk Syst Zygoma Healing Abutment Ø4x5mm; 45° Multi-unit Abutment Ext Hex RP 6mm; 45° Multi-unit Abutment Ext Hex RP 8mm; 45° Multi-unit Abutment Ext Hex RP 10mm; NobelZygoma 0° Twist Drill 2.9mm; NobelZygoma 0° Twist Drill 2.9mm Short; NobelZygoma 0° Twist Drill 3.5mm; NobelZygoma 0° Twist Drill 3.5mm Short; NobelZygoma 0° Twist Drill 4.0mm; NobelZygoma 0° Twist Drill 4.0mm Short; NobelZygoma 0° Twist Drill 4.4mm; NobelZygoma 0° Twist Drill 4.4mm Short; 60° Multi-unit Abutment Ext Hex RP 6mm; 60° Multi-unit Abutment Ext Hex RP 8mm; Zygoma Handle; Zygoma Drill Guard; Zygoma Drill Guard Short; Zygoma Depth Indicator Straight; Zygoma Depth Indicator Angled; NobelZygoma 0° 30mm; NobelZygoma 0° 35mm; NobelZygoma 0° 37.5mm; NobelZygoma 0° 40mm; NobelZygoma 0° 42.5mm; NobelZygoma 0° 45mm; NobelZygoma 0° 47.5mm; NobelZygoma 0° 50mm; NobelZygoma 45° 30mm; NobelZygoma 45° 32.5mm; NobelZygoma 45° 35mm; NobelZygoma 45° 37.5mm; NobelZygoma 45° 40mm; NobelZygoma 45° 42.5mm; NobelZygoma 45° 45mm; NobelZygoma 45° 47.5mm; NobelZygoma 45° 50mm; NobelZygoma 45° 52.5mm; NobelZygoma 0° Angled MUA Screw; Brånemark Sys Zygoma Angled MUA Screw; Impr Coping Open Tray Multi-Unit plus; Impr Coping Closed Tray Multi-unit Plus; Brånemark System® Zygoma Round Bur; Cover Screw Driver Bmk Syst Hexagon
Model identifier: 29081; 29129; 29130; 29131; 29137; 29139; 29149; 29152; 29162; 32328; 32329; 32330; 32331; 32332; 32333; 32424; 32628; 32629; 32630; 32631; 32632; 32791; 33396; 33397; 33445; 33446; 37624; 37625; 37626; 37766; 37767; 37768; 37769; 37770; 37771; 37772; 37773; 37774; 37775; 37786; 37787; 37788; 37789; 37790; 38275; 38276; 38277; 38278; 38279; 38280; 38281; 38282; 38283; 38284; 38285; 38286; 38287; 38288; 38289; 38290; 38291; 38292; 38615; 38621; 38923; 38924; DIA 578-0; DIB 097-0
Registration date: August 22, 2017
Source update date: June 05, 2025

Classification

Risk class: Class C
Published category: Dental

Published parties

Product owner: Nobel Biocare AB
Registrant / registration holder: EHC SUPPLY

Official description

Zygoma Implant System is intended to be used in the upper jaw arch (osseointegration) for anchoring or supporting prosthetic devices such as tooth replacements to restore chewing function.

Additional source fields

Product owner address: PO Box 5190, 402 26, Västra Hamngatan 1, 411 17 Göteborg, Sweden
Registrant address: 13 STAMFORD ROAD, #02-11, CAPITOL PIAZZA, Singapore 178905

About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.