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 | K181381 |
| 510k Number | K181381 |
| Device Name: | A.B. Dental Devices Dental Implants System |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | A.B Dental Device Ltd. 19 Hayalomim St. Ashdod, IL 7761117 |
| Contact | Gabi Krauss |
| Correspondent | John J. Smith Hogan Lovells US LLP 555 13th St. NW Washington, DC 20004 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-24 |
| Decision Date | 2018-11-23 |
| Summary: | summary |