The following data is part of a premarket notification filed by Implant Innovations International, Inc. with the FDA for Implarette.
| Device ID | K911655 |
| 510k Number | K911655 |
| Device Name: | IMPLARETTE |
| Classification | Burnisher, Operative |
| Applicant | IMPLANT INNOVATIONS INTERNATIONAL, INC. 1897 PALM BEACH LAKES BLVD. SUITE 114 West Palm Beach, FL 33409 |
| Contact | William Conety |
| Correspondent | William Conety IMPLANT INNOVATIONS INTERNATIONAL, INC. 1897 PALM BEACH LAKES BLVD. SUITE 114 West Palm Beach, FL 33409 |
| Product Code | EKJ |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-12 |
| Decision Date | 1991-10-21 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() IMPLARETTE 74148085 1677489 Dead/Cancelled |
IMPLANT INNOVATIONS, INC. 1991-03-15 |