FDA Registration
Active
🇫🇷 France
Biotech Dental Smilers, SAS
Reg #: 3014701704
·
FEI: 3014701704
·
Expires 2026
Products
4
Proprietary Names
5
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Biotech Dental Smilers, SAS
- Registration Number
- 3014701704
- FEI Number
- 3014701704
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 167 impasse Gaspard Monge
- City
- Salon-de-Provence Bouches-du-Rhone
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K212961
Owner / Operator
- Firm Name
- Biotech Dental Smilers, SAS
- Operator Number
- 10084087
- Address
- 305, allees de Craponne
- City
- Salon de Provence
- State
- Bouches-du-Rhone
- Postal Code
- 13300
- Country
- FR
US Agent
- Business Name
- Aclivi, LLC
- Contact Name
- Chris Brown
- Address
- 405 Tropics Ave
- City
- Daytona Beach
- State
- FL
- ZIP
- 32124
- Country
- US
- [email protected]
- Phone
- 810 3609773
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Positioner, Tooth, Preformed | KMY | Class 1 | Dental | No | 2025-03-04 |
| Aligner, Bracket, Orthodontic | ECQ | Class 1 | Dental | No | 2025-03-04 |
| Aligner, Sequential | NXC | Class 2 | Dental | No | 2022-01-17 |
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2026-05-19 |
Proprietary Names
SMILERS
FROGGYMOUTH
MYOSIMPLE
Smilers
Y-BRUSH
Establishment Types
Manufacture Medical Device