The following data is part of a premarket notification filed by A.b. Dental Devices, Ltd. with the FDA for A.b. Dental Devices Dental Implants System.
| Device ID | K132125 |
| 510k Number | K132125 |
| Device Name: | A.B. DENTAL DEVICES DENTAL IMPLANTS SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | A.B. DENTAL DEVICES, LTD. 22817 VENTURA BLVD #161 Woodland Hills, CA 91364 |
| Contact | Daniela Levy |
| Correspondent | Daniela Levy A.B. DENTAL DEVICES, LTD. 22817 VENTURA BLVD #161 Woodland Hills, CA 91364 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-10 |
| Decision Date | 2014-01-21 |
| Summary: | summary |