The following data is part of a premarket notification filed by Implant Innovations, Inc. with the FDA for Preformance Temporary Cylinder.
| Device ID | K060291 |
| 510k Number | K060291 |
| Device Name: | PREFORMANCE TEMPORARY CYLINDER |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | IMPLANT INNOVATIONS, INC. 4555 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
| Contact | Jim Banic |
| Correspondent | Jim Banic IMPLANT INNOVATIONS, INC. 4555 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-06 |
| Decision Date | 2006-02-27 |
| Summary: | summary |