The following data is part of a premarket notification filed by Sargon Ent., Inc. with the FDA for Sargon Non-expandable Dental Implant.
| Device ID | K082573 |
| 510k Number | K082573 |
| Device Name: | SARGON NON-EXPANDABLE DENTAL IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | SARGON ENT., INC. 5335 WISCONSIN AVE. NW SUITE 440 Washington, DC 20015 |
| Contact | Daniel J Manelli |
| Correspondent | Daniel J Manelli SARGON ENT., INC. 5335 WISCONSIN AVE. NW SUITE 440 Washington, DC 20015 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-05 |
| Decision Date | 2010-07-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852550007363 | K082573 | 000 |
| 00852550007264 | K082573 | 000 |
| 00852550007271 | K082573 | 000 |
| 00852550007288 | K082573 | 000 |
| 00852550007295 | K082573 | 000 |
| 00852550007301 | K082573 | 000 |
| 00852550007318 | K082573 | 000 |
| 00852550007325 | K082573 | 000 |
| 00852550007332 | K082573 | 000 |
| 00852550007349 | K082573 | 000 |
| 00852550007356 | K082573 | 000 |
| 00852550007257 | K082573 | 000 |