The following data is part of a premarket notification filed by Implant Innovations International, Inc. with the FDA for Innovative Implants And Cover Screws.
| Device ID | K874590 |
| 510k Number | K874590 |
| Device Name: | INNOVATIVE IMPLANTS AND COVER SCREWS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | IMPLANT INNOVATIONS INTERNATIONAL, INC. 1897 PALM BEACH LAKES BLVD. SUITE 114 West Palm Beach, FL 33409 |
| Contact | Richard J Lazzara |
| Correspondent | Richard J Lazzara IMPLANT INNOVATIONS INTERNATIONAL, INC. 1897 PALM BEACH LAKES BLVD. SUITE 114 West Palm Beach, FL 33409 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-09 |
| Decision Date | 1988-05-11 |