Pure Global

FKG Dental Files - HSA Registration DE0502012

Access comprehensive regulatory information for FKG Dental Files in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0502012 and owned by FKG Dentaire Sร rl. The device was registered on August 07, 2018.

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 Database
Powered by Pure Global AI
HSA Official Data
CLASS B
DE0502012
FKG Dental Files
HSA Registration Number: DE0502012
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

A device that is intended for smoothing, filing or cutting during dental procedure and typically have various forms of fine-ridged cutting surfaces along part or all of their working length. This device may be used to remove gross supragingival calculus, smooth the cementoenamel junction (CEJ), finish the margins of the teeth or other dental restorations or enlarge the root canal

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0502012
Registration Date
August 07, 2018
Change Notification Approval Date
January 22, 2025
Retention Due Date
August 06, 2025
Product Owner
Short Name
FKG Dentaire Sร rl
Address
Le Crรชt-du-Locle 4, 2322 Le Crรชt-du-Locle, SWITZERLAND
Registrant
Address
6 UBI ROAD 1, WINTECH CENTRE, #04-01, SINGAPORE 408726
Importer
Address
6 UBI ROAD 1, WINTECH CENTRE, #04-01, SINGAPORE 408726
Model Information
Model Name(s)
R-Motion Race EVO XP-endo Rise Race EVO Race EVO Race EVO Race EVO Race EVO Race EVO Race EVO Race EVO Race EVO Race EVO Race EVO Race EVO Race EVO Race EVO Race EVO R-Motion R-Motion R-Motion R-Motion R-Motion R-Motion R-Motion R-Motion R-Motion R-Motion R-Motion R-Motion Race EVO Race EVO Race EVO Race EVO Race EVO Race EVO Race EVO Race EVO Race EVO Race EVO Race EVO Race EVO Race EVO Race EVO Race EVO Race EVO Race EVO Race EVO R-Motion R-Motion R-Motion Race EVO Race EVO Race EVO Race EVO Race EVO Race EVO Race EVO Race EVO Race EVO Race EVO Race EVO Race EVO Race EVO Race EVO Race EVO Race EVO Race EVO Race EVO Race EVO XP-endo Rise Glider XP-endo Rise Glider XP-endo Rise Glider R-Motion R-Motion R-Motion R-Motion R-Motion R-Motion R-Motion Race EVO Race EVO Race EVO Race EVO Race EVO Race EVO XP-endo Finisher XP-endo Finisher XP-endo Finisher XP-endo Finisher R XP-endo Finisher R XP-endo Shaper XP-endo Shaper XP-endo Shaper XP-endo Shaper XP-endo Shaper XP-endo Shaper XP-endo Shaper XP-endo Rise Shaper XP-endo Rise Shaper XP-endo Rise Shaper XP-endo Rise Shaper XP-endo Rise Shaper XP-endo Rise Shaper Finisher Finisher Finisher Finisher R Finisher R Finisher R XP-endo Rise Sequence XP-endo Rise Retreatment XP-endo Rise Sequence XP-endo Rise Sequence XP-endo Rise Retreatment XP-endo Rise Retreatment Training Kit XP-endo Rise Retreatment Promo Set XP-endo Rise Sequence
Model Identifier(s)
99.700.80.S02.FK 99.700.80.S03.FK 99.X00.80.S05.FK S1.7B0.00.0DG.FK S1.7B0.00.0DH.FK S1.7B0.00.0DI.FK S1.7B0.00.0DJ.FK S1.7B0.00.0DK.FK S1.7B0.00.0DL.FK S1.7B0.00.0DM.FK S1.7B0.00.0DN.FK S1.7B0.00.0DO.FK S1.7B0.00.0DP.FK S1.7B0.00.0DQ.FK S1.7B0.00.0DU.FK S1.7B0.00.0DV.FK S1.7B0.00.0DW.FK S1.7B0.00.0DX.FK S1.7B0.00.0FI.FK S1.7B0.00.0FJ.FK S1.7B0.00.0FK.FK S1.7B0.00.0FL.FK S1.7B0.00.0FM.FK S1.7B0.00.0FN.FK S1.7B0.00.0FO.FK S1.7B0.00.0FP.FK S1.7B0.00.0FQ.FK S1.7B0.00.0FR.FK S1.7B0.00.0FS.FK S1.7B0.00.0FT.FK S1.7B0.00.0FU.FK S1.7B0.00.0FV.FK S1.7B0.00.0FW.FK S1.7B0.00.0FX.FK S1.7B0.00.0FY.FK S1.7B0.00.0FZ.FK S1.7B0.00.0GA.FK S1.7B0.00.0GB.FK S1.7B0.00.0GC.FK S1.7B0.00.0GD.FK S1.7B0.00.0GE.FK S1.7B0.00.0GF.FK S1.7B0.00.0GG.FK S1.7B0.00.0GH.FK S1.7B0.00.0GI.FK S1.7B0.00.0GJ.FK S1.7B0.00.0GK.FK S1.7B0.00.0GL.FK S1.7B0.00.0GM.FK S1.7B0.00.0GN.FK S1.7B0.00.0GO.FK S1.7B0.00.0GU.FK S1.7B0.00.0GV.FK S1.7B0.00.0GW.FK S1.7B0.00.0GX.FK S1.7B0.00.0GY.FK S1.7B0.00.0GZ.FK S1.7B0.00.0HA.FK S1.7B0.00.0HB.FK S1.7B0.00.0HC.FK S1.7B0.00.0HD.FK S1.7B0.00.0HE.FK S1.7B0.00.0HF.FK S1.7B0.00.0HG.FK S1.7B0.00.0HH.FK S1.7B0.00.0HI.FK S1.7B0.00.0HJ.FK S1.7B0.00.0HK.FK S1.7B0.00.0HL.FK S1.7B0.00.0HM.FK S1.7B0.00.0HN.FK S1.7B0.00.0HO.FK S1.7B0.00.0HP.FK S1.7B0.00.0HQ.FK S1.7B0.00.0HR.FK S1.7B0.00.0HS.FK S1.7B0.00.0HT.FK S1.7B0.00.0HU.FK S1.7B0.00.0HV.FK S1.7B0.00.SCT.FK S1.7B0.00.SCV.FK S1.7B0.00.SCW.FK S1.7B0.00.SCX.FK S1.7B0.00.SCY.FK S1.7B0.00.SCZ.FK S1.7B0.00.SDA.FK S1.XB0.00.0AA.FK S1.XB0.00.0AB.FK S1.XB0.00.0AC.FK S1.XB0.00.0AD.FK S1.XB0.00.0AE.FK S1.XB0.00.0AF.FK S1.XB0.00.0AG.FK S1.XB0.00.0AH.FK S1.XB0.00.0AI.FK S1.XB0.00.0AJ.FK S1.XB0.00.0AK.FK S1.XB0.00.0AL.FK S1.XB0.00.0AR.FK S1.XB0.00.0AS.FK S1.XB0.00.0AT.FK S1.XB0.00.0AU.FK S1.XB0.00.0AV.FK S1.XB0.00.0AW.FK S1.XB0.00.0AX.FK S1.XB0.00.0AY.FK S1.XB0.00.0AZ.FK S1.XB0.00.0BA.FK S1.XB0.00.0BB.FK S1.XB0.00.0BC.FK S1.XB0.00.SAG.FK S1.XB0.00.SAH.FK S1.XB0.00.SAI.FK S1.XB0.00.SAJ.FK S1.XB0.00.SAK.FK S1.XB0.00.SAL.FK S1.XB0.00.SAM.FK S1.XB0.00.SAN.FK