The following data is part of a premarket notification filed by Adin Dental Implants Systems Ltd. with the FDA for Adin Short Implants.
| Device ID | K212775 |
| 510k Number | K212775 |
| Device Name: | Adin Short Implants |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Adin Dental Implants Systems Ltd. Alon Tavor Industrial Zone, P.O. Box 1128 Afula, IL 1811101 |
| Contact | Iris Yadin-Herling |
| Correspondent | Tali Hazan Adin Dental Implants Systems Ltd. Ramot-Naftali M.P Upper Galilee, IL 1383000 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-01 |
| Decision Date | 2022-07-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290105151742 | K212775 | 000 |
| 07290105151735 | K212775 | 000 |
| 07290105151728 | K212775 | 000 |
| 07290105151292 | K212775 | 000 |
| 07290105151285 | K212775 | 000 |
| 07290105151278 | K212775 | 000 |
| 07290105150431 | K212775 | 000 |
| 07290105150417 | K212775 | 000 |