FDA Registration
Active
🇫🇷 France
BIOTECH DENTAL SAS
Reg #: 3014290448
·
FEI: 3014290448
·
Expires 2026
Products
6
Proprietary Names
6
Establishment Types
3
Classifications
6
Registration Details
- Registration Name
- BIOTECH DENTAL SAS
- Registration Number
- 3014290448
- FEI Number
- 3014290448
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 305 allees de Craponne
- City
- Salon de Provence Bouches-du-Rhone
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K212068
Owner / Operator
- Firm Name
- Biotech Dental
- Operator Number
- 10076527
- 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 |
|---|---|---|---|---|---|
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2021-11-12 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2020-11-18 |
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2026-01-06 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2022-07-20 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2022-07-20 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2020-07-22 |
Proprietary Names
Biotech Dental Kits
ATP38 Miracle
Y-BRUSH
KontactTM Dental Implant System
Kontact Dental Implant System
FIX'IN sel-drilling screw
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198