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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E0HM311511 | K122807 | 000 |
| E0HM937291 | K122807 | 000 |
| E0HM937301 | K122807 | 000 |
| E0HM937311 | K122807 | 000 |
| E0HM937321 | K122807 | 000 |
| E0HM937331 | K122807 | 000 |
| EDRS311511 | K122807 | 000 |
| EDRS311521 | K122807 | 000 |
| EDRS311531 | K122807 | 000 |
| EDRS311541 | K122807 | 000 |
| EDRS311551 | K122807 | 000 |
| EDRS356831 | K122807 | 000 |
| EDRS357361 | K122807 | 000 |
| EDRS357511 | K122807 | 000 |
| EDRS381501 | K122807 | 000 |
| EDRS384151 | K122807 | 000 |
| EDRS501251 | K122807 | 000 |
| EDRS503471 | K122807 | 000 |
| E0HM937271 | K122807 | 000 |
| E0HM932781 | K122807 | 000 |
| E0HM826471 | K122807 | 000 |
| E0HM311521 | K122807 | 000 |
| E0HM311531 | K122807 | 000 |
| E0HM311541 | K122807 | 000 |
| E0HM311551 | K122807 | 000 |
| E0HM356831 | K122807 | 000 |
| E0HM357361 | K122807 | 000 |
| E0HM357511 | K122807 | 000 |
| E0HM381501 | K122807 | 000 |
| E0HM384151 | K122807 | 000 |
| E0HM501251 | K122807 | 000 |
| E0HM503471 | K122807 | 000 |
| E0HM503481 | K122807 | 000 |
| E0HM505501 | K122807 | 000 |
| E0HM721861 | K122807 | 000 |
| E0HM721871 | K122807 | 000 |
| E0HM721991 | K122807 | 000 |
| E0HM722671 | K122807 | 000 |
| EDRS503481 | K122807 | 000 |
| EDRS505501 | K122807 | 000 |
| E0HM50357511 | K122807 | 000 |
| E0HM5041081 | K122807 | 000 |
| E0HM5041101 | K122807 | 000 |
| E0HM504110T1 | K122807 | 000 |
| E0HM5041121 | K122807 | 000 |
| E0HM504112T1 | K122807 | 000 |
| E0HM5041141 | K122807 | 000 |
| E0HM5048081 | K122807 | 000 |
| E0HM504808WP1 | K122807 | 000 |
| E0HM5048101 | K122807 | 000 |
| E0HM504810WP1 | K122807 | 000 |
| E0HM5048121 | K122807 | 000 |
| E0HM504812WP1 | K122807 | 000 |
| E0HM5048141 | K122807 | 000 |
| E0HM50937301 | K122807 | 000 |
| E0HM50937311 | K122807 | 000 |
| E0HM50937321 | K122807 | 000 |
| E0HM50357361 | K122807 | 000 |
| E0HM50356831 | K122807 | 000 |
| E0HM5033141 | K122807 | 000 |
| EDRS721861 | K122807 | 000 |
| EDRS721871 | K122807 | 000 |
| EDRS721991 | K122807 | 000 |
| EDRS722671 | K122807 | 000 |
| EDRS826471 | K122807 | 000 |
| EDRS932781 | K122807 | 000 |
| EDRS937271 | K122807 | 000 |
| EDRS937291 | K122807 | 000 |
| EDRS937301 | K122807 | 000 |
| EDRS937311 | K122807 | 000 |
| EDRS937321 | K122807 | 000 |
| EDRS937331 | K122807 | 000 |
| E0HM50311541 | K122807 | 000 |
| E0HM50311551 | K122807 | 000 |
| E0HM5033081 | K122807 | 000 |
| E0HM5033101 | K122807 | 000 |
| E0HM5033121 | K122807 | 000 |
| E0HM50937331 | K122807 | 000 |