The following data is part of a premarket notification filed by Implant Innovations, Inc. with the FDA for Conical Angled Abutment.
| Device ID | K063403 |
| 510k Number | K063403 |
| Device Name: | CONICAL ANGLED ABUTMENT |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | IMPLANT INNOVATIONS, INC. 4555 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
| Contact | Tamara Nelson |
| Correspondent | Tamara Nelson IMPLANT INNOVATIONS, INC. 4555 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-09 |
| Decision Date | 2007-03-20 |
| Summary: | summary |