The following data is part of a premarket notification filed by Implant Innovations International, Inc. with the FDA for Non-rotating Gold Cylinder And Screw.
| Device ID | K874400 |
| 510k Number | K874400 |
| Device Name: | NON-ROTATING GOLD CYLINDER AND SCREW |
| 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 | 1987-10-28 |
| Decision Date | 1988-03-02 |