The following data is part of a premarket notification filed by A.b. Dental Devices, Ltd. with the FDA for Ab Dental Devices Implants And Accessories.
| Device ID | K112440 |
| 510k Number | K112440 |
| Device Name: | AB DENTAL DEVICES IMPLANTS AND ACCESSORIES |
| Classification | Implant, Endosseous, Root-form |
| Applicant | A.B. DENTAL DEVICES, LTD. POB 367 Ramat Hasharon,, IL 47103 |
| Contact | Charles Hurwitz |
| Correspondent | Charles Hurwitz A.B. DENTAL DEVICES, LTD. POB 367 Ramat Hasharon,, IL 47103 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-24 |
| Decision Date | 2012-04-18 |
| Summary: | summary |