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 | K182455 |
| 510k Number | K182455 |
| 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 | John Smith Hogan Lovells US LLP 555 13th Street 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 | 2018-09-07 |
| Decision Date | 2019-07-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290111273954 | K182455 | 000 |
| 07290107278256 | K182455 | 000 |
| 17290107272596 | K182455 | 000 |
| 17290107272589 | K182455 | 000 |
| 17290107272572 | K182455 | 000 |
| 17290107272558 | K182455 | 000 |
| 17290107272428 | K182455 | 000 |
| 17290107272404 | K182455 | 000 |
| 17290107272398 | K182455 | 000 |
| 27290107278403 | K182455 | 000 |
| 27290107278397 | K182455 | 000 |
| 27290107272203 | K182455 | 000 |
| 27290107272197 | K182455 | 000 |
| 27290107272180 | K182455 | 000 |
| 27290107272173 | K182455 | 000 |
| 27290107272166 | K182455 | 000 |
| 27290107272159 | K182455 | 000 |
| 17290107278598 | K182455 | 000 |
| 17290107278628 | K182455 | 000 |
| 17290111272414 | K182455 | 000 |
| 17290111273947 | K182455 | 000 |
| 17290111273916 | K182455 | 000 |
| 17290111273909 | K182455 | 000 |
| 17290111273695 | K182455 | 000 |
| 17290111273671 | K182455 | 000 |
| 17290111273657 | K182455 | 000 |
| 17290111273541 | K182455 | 000 |
| 17290111273411 | K182455 | 000 |
| 17290111273404 | K182455 | 000 |
| 17290111273398 | K182455 | 000 |
| 17290111273336 | K182455 | 000 |
| 17290111273329 | K182455 | 000 |
| 17290111273220 | K182455 | 000 |
| 17290111272445 | K182455 | 000 |
| 17290111272438 | K182455 | 000 |
| 17290111272421 | K182455 | 000 |
| 27290107272029 | K182455 | 000 |