The following data is part of a premarket notification filed by Implant Innovations International, Inc. with the FDA for Surgical Drills.
| Device ID | K891615 |
| 510k Number | K891615 |
| Device Name: | SURGICAL DRILLS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | IMPLANT INNOVATIONS INTERNATIONAL, INC. 1897 PALM BEACH LAKES BLVD. SUITE 114 West Palm Beach, FL 33409 |
| Contact | J Lazzara |
| Correspondent | 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 | 1989-03-20 |
| Decision Date | 1989-04-17 |