Singapore HSA registration DE0502012

FKG Dental Files

Singapore·CLASS B·FKG Dentaire Sàrl·Registered August 07, 2018

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 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

Product Owner

Name: FKG Dentaire Sàrl
Short Name: FKG Dentaire Sàrl
Address: Le Crêt-du-Locle 4, 2322 Le Crêt-du-Locle, SWITZERLAND

Registrant

Name: Raydent Supplies (S) Pte Ltd
Address: 6 UBI ROAD 1, WINTECH CENTRE, #04-01, SINGAPORE 408726

Importer

Name: Raydent Supplies Pte. Ltd.
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

About this record

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 Sàrl. 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.

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