The following data is part of a premarket notification filed by Northern Implants, Llc with the FDA for Endosseous Dental Implant.
| Device ID | K061169 |
| 510k Number | K061169 |
| Device Name: | ENDOSSEOUS DENTAL IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NORTHERN IMPLANTS, LLC 10355 B DEMOCRACY LANE Fairfax, VA 22030 |
| Contact | Greta M Hols |
| Correspondent | Greta M Hols NORTHERN IMPLANTS, LLC 10355 B DEMOCRACY LANE Fairfax, VA 22030 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-27 |
| Decision Date | 2006-06-20 |
| Summary: | summary |