The following data is part of a premarket notification filed by Implant Innovations International, Inc. with the FDA for Post. Screw & Hex Driver/adbut & Adbut Head Driver.
| Device ID | K871862 |
| 510k Number | K871862 |
| Device Name: | POST. SCREW & HEX DRIVER/ADBUT & ADBUT HEAD DRIVER |
| Classification | Implant, Endosseous, Root-form |
| Applicant | IMPLANT INNOVATIONS INTERNATIONAL, INC. 1897 PALM BEACH LAKES BLVD. SUITE 114 West Palm Beach, FL 33409 |
| Contact | Lazzara, Dmd |
| Correspondent | Lazzara, Dmd 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 | 1987-05-13 |
| Decision Date | 1987-07-10 |