DENT4YOU AG

FDA Device Registration & Listing · Heerbrugg Sankt Gallen, CH · Registration 3022516928

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3022516928
FEI Number
3022516928
Entity Name
DENT4YOU AG
City/State/Country
Heerbrugg Sankt Gallen, CH
Establishment Address
Bahnhofstrasse 2, Heerbrugg Sankt Gallen 9435, CH
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Dent4You AG (Owner Number: 10085014)
Owner / Operator Contact Address
Bahnhofstrasse 2, Heerbrugg, CH-SG 9435, CH
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

BRAVO G4 Chamber Autoclave Dental Dam Punch ORA SHIELD HySolate Fiesta Dental Dam Clamp HySolate Brinker Dental Dam Clamp HySolate Dental Dam Clamp Dental Dam Frame STATCLEAN BRILLIANT Crios HYDRIM C61WD G4 Instrument Washer-Disinfector STATIM 2000 G4 Cassette Autoclave STATIM 5000 G4 Cassette Autoclave SPEEDEX PRESIDENT Tray Coltolux Comfort LED Curing Light Alpen Carbide Alpen Speedster JET BLUE BITE FAST JET BLUE BITE SUPERFAST JET BITE BioSonic US200 UltraSonic Scaler HIP Ultra Cleaning Solution HYDRIM L110W G4 Instrument Washer HYDRIM C61W G4 Instrument Washer HYDRIM L110W Instrument Washer HIP Cleaning Solution HYDRIM 112W G4+ Instrument Washer HIP Cleaning Solution with Instrument Protection for HYDRIM 112 BRILLIANT EverGlow STATCARE Handpiece Spray STATMATIC Spray PRESIDENT The Original AFFINIS Adhesive AC Adhesive BRILLIANT EverGlow Flow BRILLIANT Bulk Fill Flow Diatech Diamond Instruments Alpen Diamond Instruments

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FLE Sterilizer, Steam General Hospital Class 2 880.6880 2024-03-06
EJB Handle, Instrument, Dental Dental Class 1 872.4565 2023-01-10
KHR Absorber, Saliva, Paper Dental Class 1 872.6050 2023-01-10
EEF Clamp, Rubber Dam Dental Class 1 872.6300 2023-01-10
EJE Frame, Rubber Dam Dental Class 1 872.6300 2023-01-10
FLG Cleaner, Ultrasonic, Medical Instrument General Hospital Class 1 880.6150 2025-07-30
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2026-02-02
MEC Disinfector, Medical Devices General Hospital Class 2 880.6992 2024-03-06
FLE Sterilizer, Steam General Hospital Class 2 880.6880 2024-03-06
ELW Material, Impression Dental Class 2 872.3660 2025-04-17
EHY Tray, Impression, Preformed Dental Class 1 872.6880 2025-02-05
EBZ Activator, Ultraviolet, For Polymerization Dental Class 2 872.6070 2023-01-04
EJL Bur, Dental Dental Class 1 872.3240 2024-08-14
ELW Material, Impression Dental Class 2 872.3660 2026-01-06
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2024-07-24
LDS Device, Pasteurization, Hot Water General Hospital Class 2 880.6991 2024-03-06
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2026-04-24
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2026-01-05
ELW Material, Impression Dental Class 2 872.3660 2025-04-17
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2026-03-13
DZP Instrument, Diamond, Dental Dental Class 1 872.4535 2023-08-07

Official Correspondent

Tricia Cregger

US Agent Details

Tricia Cregger Email: tricia.cregger@coltene.com Phone: (330) 9168904

Related Public Records

Same Entity

Dent4You AG
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K021223 Sauter AG BELIMED STEAM STERILIZER, MODEL TOP 5000 2002-06-26
K050263 M.O. Com S.R.L. MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU 2006-11-21
K952662 Jeneric/Pentron, Inc. COMP=FLOW 1995-08-28
K171147 Bisco, Inc. REVEAL Bulk 2017-08-04
K770922 Espe GmbH (Us) DENTAL RESTORATIVE IN CAPSULES 1977-06-01

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0008-2025 Young Dental Manufacturing I, LLC 1
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
Z-0028-2020 Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany 2
Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
Z-0016-2026 Getinge Disinfection Ab Ljungadalsgatan 2
Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
Z-0018-2014 Getinge Disinfection Ljungadalsgatan 2
Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The washer disinfector is used in healthcare facilities where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
Z-0036-2011 Cenorin 2
HLD SYSTEM 520 is a two-tank Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers). Each unit has a metal serial tag that is riveted to the enclosure of the unit and it is labeled in part: "HLD SYSTEMS 520***FOR SALES.SERVICE.SUPPLIES CALL***Cenorin*** Kent, WA 98032***P:800.426.1042***F: 253.395.2650***www.cenorin.com". Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers) are intended to use at healthcare provide clinical areas such as sleep labs, central services, sterile processing, respiratory care departments. The system is used to clean and high level disinfecting medical devices. They are designed to automate the pre-washing and rinsing of critical devices prior to sterilization in other devices.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022516928. Last updated year: 2026. Please use registration number 3022516928 when referencing this establishment in official correspondence.
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