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Data / Medical devices / Switzerland / Dent4you AG

Dent4you AG: FDA-registered device maker in Heerbrugg Sankt Gallen, Switzerland, 16 510(k) clearances

Dent4you AG is registered with the FDA (registration 3022516928) in Heerbrugg Sankt Gallen, Switzerland. It lists 22 device types. The FDA files 16 510(k) clearances under its listings, the newest dated June 27, 2025. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Dent4you AG
FDA registration number
3022516928
Address
Bahnhofstrasse 2, Heerbrugg Sankt Gallen, Switzerland, 9435
Owner or operator
Dent4You AG (10085014)
Roles
Specification developer
First device listed
April 26, 2022
Registered through
2026
Brand names listed
AFFINIS, Adhesive, Adhesive AC, Alpen Carbide, Alpen Diamond Instruments, Alpen Speedster, BRAVO G4 Chamber Autoclave, BRILLIANT Bulk Fill Flow and more

Devices it lists

DeviceProduct codeClassRoleSource
Absorber, Saliva, PaperKHR1Specification developeraccessdata.fda.gov
Activator, Ultraviolet, For PolymerizationEBZ2Specification developeraccessdata.fda.gov
Agent, Tooth Bonding, ResinKLE2Specification developeraccessdata.fda.gov
Bur, DentalEJL1Specification developeraccessdata.fda.gov
Clamp, Rubber DamEEF1Specification developeraccessdata.fda.gov
Cleaner, Ultrasonic, Medical InstrumentFLG1Specification developeraccessdata.fda.gov
Dam, RubberEIE1Specification developeraccessdata.fda.gov
Device, Pasteurization, Hot WaterLDS2Specification developeraccessdata.fda.gov
Disinfector, Medical DevicesMEC2Specification developeraccessdata.fda.gov
Forceps, Rubber Dam ClampEJG1Specification developeraccessdata.fda.gov
Frame, Rubber DamEJE1Specification developeraccessdata.fda.gov
Handle, Instrument, DentalEJB1Specification developeraccessdata.fda.gov
Handpiece, Air-Powered, DentalEFB1Specification developeraccessdata.fda.gov
Instrument, Diamond, DentalDZP1Specification developeraccessdata.fda.gov
Material, ImpressionELW2Specification developeraccessdata.fda.gov
Material, Tooth Shade, ResinEBF2Specification developeraccessdata.fda.gov
Post, Root CanalELR1Specification developeraccessdata.fda.gov
Scaler, UltrasonicELC2Specification developeraccessdata.fda.gov
Sterilizer, SteamFLE2Specification developeraccessdata.fda.gov
Syringe, Restorative And Impression MaterialEID1Specification developeraccessdata.fda.gov
Tray, Impression, PreformedEHY1Specification developeraccessdata.fda.gov
Wheel, Polishing AgentEJQ1Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
June 27, 2025K250969JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFASTELWSubstantially EquivalentDent4you AGaccessdata.fda.gov
November 15, 2024K242360Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal ActivatorELWSubstantially EquivalentDent4you AGaccessdata.fda.gov
July 1, 2024K240801BioSonic US200 Ultrasonic Scaler (60034537)ELCSubstantially EquivalentDent4you AGaccessdata.fda.gov
December 22, 2022K223142Coltolux Comfort LED Curing LightEBZSubstantially EquivalentDent4you AGaccessdata.fda.gov
January 13, 2022K220097PRESIDENT The OriginalELWSubstantially EquivalentColtène/Whaledent AGaccessdata.fda.gov
July 1, 2021K210326Bravo G4 Chamber AutoclaveFLESubstantially EquivalentScican , Ltd.accessdata.fda.gov
June 19, 2020K192910STATClave G4 Chamber AutoclaveFLESubstantially EquivalentScican , Ltd.accessdata.fda.gov
July 26, 2019K190062STATCLAVE G4 Chamber AutoclaveFLESubstantially EquivalentScican , Ltd.accessdata.fda.gov
June 21, 2019K190597BRILLIANT EverGlow FlowEBFSubstantially EquivalentColtene/Whaledent AGaccessdata.fda.gov
August 15, 2018K181500BRILLIANT CriosEBFSubstantially EquivalentColtene/Whaledent AGaccessdata.fda.gov
April 28, 2016K152927BRILLIANT EVERGLOWEBFSubstantially EquivalentColtene/Whaledent AGaccessdata.fda.gov
December 9, 2015K152243One Coat 7 UniversalKLESubstantially EquivalentColtene/Whaledent AGaccessdata.fda.gov
July 10, 2012K112872STATIM 2000 G4 CASSETTEFLESubstantially EquivalentScican , Ltd.accessdata.fda.gov
October 19, 2006K062418K-SPRAY, MODEL 085-2715EFBSubstantially EquivalentScicanaccessdata.fda.gov
January 9, 2006K052820PARAPOST PARACORE AUTOMIX 5MLEBFSubstantially EquivalentColtene/Whaledent AGaccessdata.fda.gov
January 4, 1999K983679STATIM 5000 CASSETTE AUTOCLAVEFLESubstantially EquivalentScicanaccessdata.fda.gov

Compare with other makers

Updated June 27, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.