The following data is part of a premarket notification filed by Denovis Medical, Llc with the FDA for Denovismed Dental Implant Systems.
| Device ID | K083543 |
| 510k Number | K083543 |
| Device Name: | DENOVISMED DENTAL IMPLANT SYSTEMS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | DENOVIS MEDICAL, LLC 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Contact | Kevin A Thomas |
| Correspondent | Kevin A Thomas DENOVIS MEDICAL, LLC 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-28 |
| Decision Date | 2009-03-06 |
| Summary: | summary |