The following data is part of a premarket notification filed by Adin Dental Implants System Ltd with the FDA for Adin Dental Implants System.
| Device ID | K081751 |
| 510k Number | K081751 |
| Device Name: | ADIN DENTAL IMPLANTS SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ADIN DENTAL IMPLANTS SYSTEM LTD INDUSTRIAL PARK 13 M.P. MISGAV Mizpe Aviv, IL 20187 |
| Contact | Benny Arazy |
| Correspondent | Benny Arazy ADIN DENTAL IMPLANTS SYSTEM LTD INDUSTRIAL PARK 13 M.P. MISGAV Mizpe Aviv, 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 | 2008-06-19 |
| Decision Date | 2008-12-19 |