FDA Registration
Active
🇨🇭 Switzerland
DENT4YOU AG
Reg #: 3022516928
·
FEI: 3022516928
·
Expires 2026
Products
20
Proprietary Names
49
Establishment Types
1
Classifications
20
Registration Details
- Registration Name
- DENT4YOU AG
- Registration Number
- 3022516928
- FEI Number
- 3022516928
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Bahnhofstrasse 2
- City
- Heerbrugg Sankt Gallen
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K210326
Owner / Operator
- Firm Name
- Dent4You AG
- Operator Number
- 10085014
- Address
- Bahnhofstrasse 2
- City
- Heerbrugg
- State
- Sankt Gallen
- Postal Code
- 9435
- Country
- CH
- Correspondent
- Tricia Cregger
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sterilizer, Steam | FLE | Class 2 | General Hospital | No | 2024-03-06 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2023-01-10 |
| Absorber, Saliva, Paper | KHR | Class 1 | Dental | No | 2023-01-10 |
| Clamp, Rubber Dam | EEF | Class 1 | Dental | No | 2023-01-10 |
| Frame, Rubber Dam | EJE | Class 1 | Dental | No | 2023-01-10 |
| Cleaner, Ultrasonic, Medical Instrument | FLG | Class 1 | General Hospital | No | 2025-07-30 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2026-02-02 |
| Disinfector, Medical Devices | MEC | Class 2 | General Hospital | No | 2024-03-06 |
| Material, Impression | ELW | Class 2 | Dental | No | 2025-04-17 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2025-02-05 |
| Activator, Ultraviolet, For Polymerization | EBZ | Class 2 | Dental | No | 2023-01-04 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2024-08-14 |
| Scaler, Ultrasonic | ELC | Class 2 | Dental | No | 2024-07-24 |
| Device, Pasteurization, Hot Water | LDS | Class 2 | General Hospital | No | 2024-03-06 |
| Handpiece, Air-Powered, Dental | EFB | Class 1 | Dental | No | 2026-01-05 |
| Instrument, Diamond, Dental | DZP | Class 1 | Dental | No | 2023-08-07 |
| Wheel, Polishing Agent | EJQ | Class 1 | Dental | No | 2025-07-23 |
| Post, Root Canal | ELR | Class 1 | Dental | No | 2025-02-03 |
| Dam, Rubber | EIE | Class 1 | Dental | No | 2022-04-26 |
| Forceps, Rubber Dam Clamp | EJG | Class 1 | Dental | No | 2022-12-27 |
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
STATCLAVE G4 Chamber Autoclave
KENDA
STATIM 5000 G4 Cassette Autoclave, Extended
STATCLAVE G4 Chamber Autoclave, 208-240V
ParaPost Fiber White
ParaPost Taper Lux
ParaPost Fiber Lux
HySolate Dental Dam
HySolate Wedjet
Dental Dam Forceps
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility