The following data is part of a premarket notification filed by A.b. Dental Devices, Ltd. with the FDA for A.b. Dental Devices.
| Device ID | K051719 |
| 510k Number | K051719 |
| Device Name: | A.B. DENTAL DEVICES |
| Classification | Implant, Endosseous, Root-form |
| Applicant | A.B. DENTAL DEVICES, LTD. MITZPE AVIV INDUSTRIAL PARK 13 M.p. Misgav, IL 20187 |
| Contact | Benny Arazy |
| Correspondent | Benny Arazy A.B. DENTAL DEVICES, LTD. MITZPE AVIV INDUSTRIAL PARK 13 M.p. Misgav, IL 20187 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-27 |
| Decision Date | 2006-03-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290107270646 | K051719 | 000 |
| 17290107270639 | K051719 | 000 |