Dental Device Guide
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Manufacturer registered with FDA

Dent4You AG

Heerbrugg, Switzerland. Lists 18 dental device types with FDA across 1 registered establishment, and holds 5 510(k) clearances as applicant.

FDA owner/operator10085014Specification developer5 clearances in five years
Device types listed
18
Brands and models
37
510(k) clearances
52022–2026
Markets registered in
12309 registrations outside the US
Establishments
1Switzerland
2022: 12024: 22025: 12026: 120102020

510(k) clearances per year, 2007–2026

Registered in 12 markets

Where regulators' registries name Dent4You AG as the manufacturer or the registration holder of a device.

All markets
United States: 18 device types listedColombia: 90 registrationsEuropean Union: 75 registrationsCanada: 69 registrationsAustralia: 28 registrationsBrazil: 20 registrationsPeru: 8 registrationsTaiwan: 8 registrationsChina: 4 registrationsIsrael: 4 registrationsSerbia: 2 registrationsSouth Korea: 1 registrations
RegisteredHome: SwitzerlandOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerDent4You AG5 clearances2022–2026Below
ColombiaINVIMAManufacturerDENT4YOU AG.DENT4YOU AG90—Pure Global AI
European UnionEUDAMEDManufacturerDent4You AGDent4you GmbH75—Pure Global AI
CanadaHealth CanadaRegistration holderDENT4YOU AG691999–2026Pure Global AI
AustraliaTGAManufacturerDent4You AG282021–2026Pure Global AI
BrazilANVISAManufacturerDENT4YOU AG202024–2026Pure Global AI
PeruDIGEMIDManufacturerDENT4YOU AG82023–2025Pure Global AI
TaiwanTFDAManufacturerDent4You AG82006–2026Pure Global AI
ChinaNMPARegistration holder瑞士康特Dent4You AG瑞士康特 Dent4You AG4—Pure Global AI
IsraelAMARManufacturerDent4You AG4—Pure Global AI
SerbiaALIMSManufacturerDent4You AG22023–2023Pure Global AI
South KoreaMFDSManufacturerDent4You AG12026–2026Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What Dent4You AG currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Resin Tooth Shade MaterialEBF · Class 2Dental compositesMaker
BRILLIANT Bulk Fill FlowBRILLIANT CriosBRILLIANT EverGlowBRILLIANT EverGlow FlowParaCore
2026
Impression MaterialELW · Class 2Impression materialsMaker
AdhesiveAdhesive ACAFFINISJET BITEJET BLUE BITE FASTJET BLUE BITE SUPERFASTPRESIDENT The OriginalSPEEDEX
2025
Dental Diamond InstrumentDZP · Class 1Dental burs & diamondsMaker
Alpen Diamond InstrumentsDiatech Diamond Instruments
2023
Ultraviolet Activator for PolymerizationEBZ · Class 2Curing lightsMaker
Coltolux Comfort LED Curing Light
2023
Rubber Dam ClampEEF · Class 1Rubber dam systemsMaker
HySolate Brinker Dental Dam ClampHySolate Dental Dam ClampHySolate Fiesta Dental Dam Clamp
2023
Dental Air-Powered HandpieceEFB · Class 1Dental handpiecesMaker
STATCARE Handpiece SpraySTATMATIC Spray
2026
Preformed Impression TrayEHY · Class 1Impression traysMaker
PRESIDENT Tray
2025
Restorative and Impression Material SyringeEID · Class 1Dental hand instrumentsMaker
Mixing Tips
2026
Rubber DamEIE · Class 1Rubber dam systemsMaker
HySolate Dental DamHySolate Wedjet
2022
Dental Instrument HandleEJB · Class 1Dental hand instrumentsMaker
Dental Dam Punch
2023
Rubber Dam FrameEJE · Class 1Rubber dam systemsMaker
Dental Dam Frame
2023
Rubber Dam Clamp ForcepsEJG · Class 1Rubber dam systemsMaker
Dental Dam Forceps
2022
Dental BurEJL · Class 1Dental burs & diamondsMaker
Alpen CarbideAlpen Speedster
2024
Polishing Agent WheelEJQ · Class 1Polishing & prophylaxisMaker
KENDA
2025
Ultrasonic ScalerELC · Class 2Ultrasonic scalersMaker
BioSonic US200 UltraSonic Scaler
2024
Root Canal PostELR · Class 1Root canal filling materialsMaker
ParaPost Fiber LuxParaPost Fiber WhiteParaPost Taper Lux
2025
Paper Saliva AbsorberKHR · Class 1—Maker
ORA SHIELD
2023
Resin Tooth Bonding AgentKLE · Class 2Bonding agentsMaker
One Coat 7 Universal
2026

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Dent4You AG as the applicant.

Decided510(k)DeviceDevice type
8 Oct 2026K263680One Coat Bond; One Coat Bond SLKLE Resin Tooth Bonding Agent
27 Jun 2025K250969JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFASTELW Impression Material
15 Nov 2024K242360Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal ActivatorELW Impression Material
1 Jul 2024K240801BioSonic US200 Ultrasonic Scaler (60034537)ELC Ultrasonic Scaler
22 Dec 2022K223142Coltolux Comfort LED Curing LightEBZ Ultraviolet Activator for Polymerization

Also lists devices cleared under other names

Dent4You AG lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Coltene/Whaledent AG (7).

Decided510(k)DeviceApplicantDevice type
13 Jan 2022K220097PRESIDENT The OriginalColtene/Whaledent AGELW Impression Material
21 Jun 2019K190597BRILLIANT EverGlow FlowColtene/Whaledent AGEBF Resin Tooth Shade Material
15 Aug 2018K181500BRILLIANT CriosColtene/Whaledent AGEBF Resin Tooth Shade Material
28 Apr 2016K152927BRILLIANT EVERGLOWColtene/Whaledent AGEBF Resin Tooth Shade Material
9 Dec 2015K152243One Coat 7 UniversalColtene/Whaledent AGKLE Resin Tooth Bonding Agent
19 Oct 2006K062418K-SPRAY, MODEL 085-2715Coltene/Whaledent AGEFB Dental Air-Powered Handpiece
9 Jan 2006K052820PARAPOST PARACORE AUTOMIX 5MLColtene/Whaledent AGEBF Resin Tooth Shade Material

Registered establishments

EstablishmentLocationWhat it does
DENT4YOU AGFDA reg. 3022516928Heerbrugg Sankt Gallen, SwitzerlandSpecification developer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10085014). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.