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 |