The following data is part of a premarket notification filed by Hager & Meisinger Gmbh with the FDA for Dental Implant System.
| Device ID | K122807 |
| 510k Number | K122807 |
| Device Name: | DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | HAGER & MEISINGER GMBH 7440 S. TUCSON WAY SUITE 130 Centennial, CO 80112 |
| Contact | Alex Miller |
| Correspondent | Alex Miller HAGER & MEISINGER GMBH 7440 S. TUCSON WAY SUITE 130 Centennial, CO 80112 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-30 |
| Decision Date | 2014-06-13 |