The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Jne Implant System.
| Device ID | K072425 |
| 510k Number | K072425 |
| Device Name: | JNE IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | GC AMERICA, INC. 1025 EVERETT ROAD, SUITE 100 Lake Forest, IL 60045 |
| Contact | Carl Jenkins |
| Correspondent | Carl Jenkins GC AMERICA, INC. 1025 EVERETT ROAD, SUITE 100 Lake Forest, IL 60045 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-29 |
| Decision Date | 2008-03-10 |
| Summary: | summary |