Data / Medical devices / France / Biotech Dental Smilers, SAS
Biotech Dental Smilers, SAS: FDA-registered device maker in Salon-de-Provence Bouches-du-Rhone, France, 1 510(k) clearance
Biotech Dental Smilers, SAS is registered with the FDA (registration 3014701704) in Salon-de-Provence Bouches-du-Rhone, France. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 20, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014701704
- Address
- 167 impasse Gaspard Monge, Salon-de-Provence Bouches-du-Rhone, France, 13300
- Owner or operator
- Biotech Dental Smilers, SAS (10084087)
- Roles
- Manufacturer
- First device listed
- January 17, 2022
- Registered through
- 2026
- Brand names listed
- FROGGYMOUTH, MYOSIMPLE, SMILERS, Smilers, Y-BRUSH
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aligner, Bracket, Orthodontic | ECQ | 1 | Manufacturer | accessdata.fda.gov |
| Aligner, Sequential | NXC | 2 | Manufacturer | accessdata.fda.gov |
| Positioner, Tooth, Preformed | KMY | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| September 20, 2021 | K212961 | SMILERS | NXC | Substantially Equivalent | Biotech Dental Smilers, Sas | accessdata.fda.gov |
Compare with other makers
- All makers of Positioner, Tooth, Preformed
- All makers of Toothbrush, Powered
- All makers of Aligner, Bracket, Orthodontic
- All makers of Aligner, Sequential
Updated September 20, 2021. 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.