The following data is part of a premarket notification filed by Northern Implants, Llc with the FDA for Endosseous Dental Implant System.
| Device ID | K053478 |
| 510k Number | K053478 |
| 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 | 2005-12-14 |
| Decision Date | 2006-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06009544000587 | K053478 | 000 |
| 06009544019572 | K053478 | 000 |
| 06009544019602 | K053478 | 000 |
| 06009544019619 | K053478 | 000 |
| 06009544019626 | K053478 | 000 |
| 06009544019633 | K053478 | 000 |
| 06009544019640 | K053478 | 000 |
| 06009544019657 | K053478 | 000 |
| 06009544019701 | K053478 | 000 |
| 06009544019725 | K053478 | 000 |
| 06009544019749 | K053478 | 000 |
| 06009544019756 | K053478 | 000 |
| 06009544019770 | K053478 | 000 |
| D768SCNU20 | K053478 | 000 |
| D768TBN20 | K053478 | 000 |
| D768TBN30 | K053478 | 000 |
| D768TBN40 | K053478 | 000 |
| 06009544019565 | K053478 | 000 |
| 06009544019558 | K053478 | 000 |
| 06009544019541 | K053478 | 000 |
| 06009544000594 | K053478 | 000 |
| 06009544000600 | K053478 | 000 |
| 06009544000617 | K053478 | 000 |
| 06009544000624 | K053478 | 000 |
| 06009544021315 | K053478 | 000 |
| 06009544028284 | K053478 | 000 |
| 06009544019718 | K053478 | 000 |
| 06009544019732 | K053478 | 000 |
| 06009544019886 | K053478 | 000 |
| 06009544007555 | K053478 | 000 |
| 06009544019459 | K053478 | 000 |
| 06009544019466 | K053478 | 000 |
| 06009544019473 | K053478 | 000 |
| 06009544019497 | K053478 | 000 |
| 06009544019527 | K053478 | 000 |
| 06009544019534 | K053478 | 000 |
| D768TBN60 | K053478 | 000 |
| D768WBN20 | K053478 | 000 |
| 06009544010005 | K053478 | 000 |
| 06009544018162 | K053478 | 000 |
| 06009544019442 | K053478 | 000 |
| 06009544019480 | K053478 | 000 |
| 06009544021261 | K053478 | 000 |
| 06009544021278 | K053478 | 000 |
| 06009544021285 | K053478 | 000 |
| 06009544021292 | K053478 | 000 |
| 06009544021308 | K053478 | 000 |
| 06009544021698 | K053478 | 000 |
| 06009544021704 | K053478 | 000 |
| 06009544021711 | K053478 | 000 |
| 06009544021728 | K053478 | 000 |
| 06009544023494 | K053478 | 000 |
| 06009544023500 | K053478 | 000 |
| 06009544023517 | K053478 | 000 |
| 06009544009993 | K053478 | 000 |
| 06009544009986 | K053478 | 000 |
| 06009544009979 | K053478 | 000 |
| D768WBN30 | K053478 | 000 |
| D768WBN40 | K053478 | 000 |
| D768WBN60 | K053478 | 000 |
| D768ABNMC10 | K053478 | 000 |
| D768ABNMC30 | K053478 | 000 |
| D768ABNMC50 | K053478 | 000 |
| D768DBNS120 | K053478 | 000 |
| D768DN20 | K053478 | 000 |
| D768DN350 | K053478 | 000 |
| D768DN50 | K053478 | 000 |
| D768GCEX340 | K053478 | 000 |
| D768GCNX340 | K053478 | 000 |
| 06009544007425 | K053478 | 000 |
| 06009544008316 | K053478 | 000 |
| 06009544009955 | K053478 | 000 |
| 06009544009962 | K053478 | 000 |
| 06009544023524 | K053478 | 000 |