The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Gc Aadva Abutment- Zirconium-bo Ac Bh Sv.
| Device ID | K113816 |
| 510k Number | K113816 |
| Device Name: | GC AADVA ABUTMENT- ZIRCONIUM-BO AC BH SV |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | GC AMERICA, INC. 10 E. SCRANTON AVENUE SUITE 201 Lake Bluff, IL 60044 |
| Contact | Carl H Jenkins |
| Correspondent | Carl H Jenkins GC AMERICA, INC. 10 E. SCRANTON AVENUE SUITE 201 Lake Bluff, IL 60044 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-27 |
| Decision Date | 2013-01-30 |
| Summary: | summary |