The following data is part of a premarket notification filed by Implant Innovations, Inc. with the FDA for Certain Prevail Dental Implant.
| Device ID | K061629 |
| 510k Number | K061629 |
| Device Name: | CERTAIN PREVAIL DENTAL IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | IMPLANT INNOVATIONS, INC. 4555 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
| Contact | Jim Banic |
| Correspondent | Jim Banic IMPLANT INNOVATIONS, INC. 4555 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-12 |
| Decision Date | 2007-02-23 |
| Summary: | summary |