The following data is part of a premarket notification filed by A.b. Dental Device Ltd. with the FDA for A.b. Dental Devices Dental Implants System.
| Device ID | K202144 |
| 510k Number | K202144 |
| Device Name: | A.B. Dental Devices Dental Implants System |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | A.B. Dental Device Ltd. 19 Hayalomim Street Ashdod, IL 7761117 |
| Contact | Gabi Krauss |
| Correspondent | Nissim Shaked Nissim Shaked RA Specialist 17th Tel-Hay St. Raanana, IL 4340525 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-31 |
| Decision Date | 2022-09-23 |