The following data is part of a premarket notification filed by Intra-lock International with the FDA for Mini Drive-lock Dental Implant System Prosthetics.
| Device ID | K080598 |
| 510k Number | K080598 |
| Device Name: | MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | INTRA-LOCK INTERNATIONAL 6560 WEST ROGERS CIRCLE SUITE 24 Boca Raton, FL 33487 |
| Contact | Jeffrey Sakoff |
| Correspondent | Jeffrey Sakoff INTRA-LOCK INTERNATIONAL 6560 WEST ROGERS CIRCLE SUITE 24 Boca Raton, FL 33487 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-03 |
| Decision Date | 2008-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D742MDLSAP0 | K080598 | 000 |
| 00847236017170 | K080598 | 000 |
| 00847236014704 | K080598 | 000 |
| 00847236014698 | K080598 | 000 |
| 00847236014667 | K080598 | 000 |