The following data is part of a premarket notification filed by Northern Implants, Llc with the FDA for Endosseous Dental Implant System.
| Device ID | K052490 |
| 510k Number | K052490 |
| Device Name: | ENDOSSEOUS DENTAL IMPLANT SYSTEM |
| 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 | 2005-09-12 |
| Decision Date | 2005-12-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06009544001591 | K052490 | 000 |
| 06009544023272 | K052490 | 000 |
| 06009544023289 | K052490 | 000 |
| 06009544007593 | K052490 | 000 |
| 06009544001171 | K052490 | 000 |
| 06009544001188 | K052490 | 000 |
| 06009544001195 | K052490 | 000 |
| 06009544001201 | K052490 | 000 |
| 06009544001218 | K052490 | 000 |
| 06009544001553 | K052490 | 000 |
| 06009544001560 | K052490 | 000 |
| 06009544001577 | K052490 | 000 |
| 06009544001584 | K052490 | 000 |
| 06009544019893 | K052490 | 000 |