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Singapore HSA registration DE0500499

EMS Dental scaling system, pneumatic

Singapore flagSingapore·CLASS B·E.M.S Electro Medical Systems S.A·Registered March 06, 2017
Device classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration information
Registration Number
DE0500499
Registration Date
March 06, 2017
Retention Due Date
March 05, 2026
Product description
An assembly of devices designed to use compressed air to generate a vibrating action at its point of patient contact for the removal of accretions from tooth surfaces during dental cleaning or periodontal (gum) therapy. The handpiece may connect to an existing air driven handpiece tubing and the water spray for lavage. This device is used for procedures that may involve the removal of plaque, biofilm, or gross calculus from shallow to deep periodontal pockets. It can be also used for the removal of orthodontic cement.
Product Owner
Name
E.M.S Electro Medical Systems S.A
Short Name
E.M.S Electro Medical Systems S.A
Address
Chemin de la Vuarpilliere 31, 1260 Nyon, SWITZERLAND
Registrant
Name
Fondaco Pte Ltd
Address
7 KAKI BUKIT ROAD 1, Eunos Techno Link, #03-06, SINGAPORE 415937
Importer
Name
Fondaco Pte Ltd
Address
7 KAKI BUKIT ROAD 1, Eunos Techno Link, #03-06, SINGAPORE 415937
Model information
Model Name(s)
Instrument A with CombiTorque File Holder 120Degrees Instrument P with CombiTorque Instrument PS with CombiTorque AIR-FLOW handpiece 120Degrees PERIO-FLOW handpiece AIR-FLOW handy 3.0 handpiece AIR-FLOW PERIO handy 3.0 PERIO handpiece AIR-FLOW PLUS handy 3.0 PERIO handpiece Piezon handpiece AIR-FLOW HANDY 2+ AIR-FLOW HANDY 3.0 AIR-FLOW HANDY 3.0 PERIO
Model Identifier(s)
DS-001A DS-010A DS-011A DS-016A EL-308# EL-354# EL-540# EL-542# EL-545# EN-046# FT-170# FT-220# FT-221#
About this record

Access comprehensive regulatory information for EMS Dental scaling system, pneumatic in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0500499 and owned by E.M.S Electro Medical Systems S.A. The device was registered on March 06, 2017.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B