Data / Medical devices / France / Biotech Dental SAS
Biotech Dental SAS: FDA-registered device maker in Salon de Provence Bouches-du-Rhone, France, 3 510(k) clearances
Biotech Dental SAS is registered with the FDA (registration 3014290448) in Salon de Provence Bouches-du-Rhone, France. It lists 6 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 15, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014290448
- Address
- 305 allees de Craponne, Salon de Provence Bouches-du-Rhone, France, 13300
- Owner or operator
- Biotech Dental (10076527)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- July 22, 2020
- Registered through
- 2026
- Brand names listed
- ATP38 Miracle, Biotech Dental Kits, FIX'IN sel-drilling screw, Kontact Dental Implant System, KontactTM Dental Implant System, Y-BRUSH
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Toothbrush, Powered | JEQ | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 15, 2022 | K213997 | Kontact Dental Implant System | DZE | Substantially Equivalent | Biotech Dental, Sas | accessdata.fda.gov |
| November 8, 2021 | K212068 | Biotech Dental Kits | KCT | Substantially Equivalent | Biotech Dental, Sas | accessdata.fda.gov |
| June 18, 2021 | K210220 | Kontact Dental Implant System | DZE | Substantially Equivalent | Biotech Dental, Sas | accessdata.fda.gov |
Compare with other makers
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Implant, Endosseous, Root-Form
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of Toothbrush, Powered
- All makers of Accessories, Implant, Dental, Endosseous
Updated July 15, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.