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 | K162482 |
| 510k Number | K162482 |
| Device Name: | A.B. DENTAL DEVICES Dental Implants System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | A. B. Dental Device Ltd. 19 Hayalomim St. Ashdod, IL 77101 |
| Contact | Gabi Krauss |
| Correspondent | John Smith Hogan Lovells US LLP 555 13th St. NW Washington, DC 20004 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-06 |
| Decision Date | 2017-09-15 |
| Summary: | summary |