The following data is part of a premarket notification filed by Biotech Dental, Sas with the FDA for Biotech Dental Kits.
| Device ID | K212068 |
| 510k Number | K212068 |
| Device Name: | Biotech Dental Kits |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | Biotech Dental, SAS 305 Allées De Craponne Salon De Provence, FR 13300 |
| Contact | Delphine Mercier |
| Correspondent | Melissa Burbage PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-02 |
| Decision Date | 2021-11-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03701045244714 | K212068 | 000 |
| 03701045243526 | K212068 | 000 |
| 03701045243540 | K212068 | 000 |
| 03701045243618 | K212068 | 000 |
| 03701045243694 | K212068 | 000 |
| 03701045243700 | K212068 | 000 |
| 03701045245032 | K212068 | 000 |
| 03701045245049 | K212068 | 000 |
| 03701045270645 | K212068 | 000 |
| 03701045270652 | K212068 | 000 |
| 03701045240181 | K212068 | 000 |
| 03701045240525 | K212068 | 000 |
| 03701045240709 | K212068 | 000 |
| 03701045243762 | K212068 | 000 |
| 03701045243779 | K212068 | 000 |
| 03701045243786 | K212068 | 000 |
| 03701045244707 | K212068 | 000 |
| 03701045243519 | K212068 | 000 |