The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Gc Aadva Abutment.
| Device ID | K072100 |
| 510k Number | K072100 |
| Device Name: | GC AADVA ABUTMENT |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | GC AMERICA, INC. 1025 EVERETT ROAD, SUITE 100 Lake Forest, IL 60045 |
| Contact | H. Carl Jenkins |
| Correspondent | H. Carl Jenkins GC AMERICA, INC. 1025 EVERETT ROAD, SUITE 100 Lake Forest, IL 60045 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-31 |
| Decision Date | 2008-02-14 |