The following data is part of a premarket notification filed by Gac Intl., Inc. with the FDA for Ion-implanted Neo Sentalloy.
| Device ID | K932025 |
| 510k Number | K932025 |
| Device Name: | ION-IMPLANTED NEO SENTALLOY |
| Classification | Bracket, Metal, Orthodontic |
| Applicant | GAC INTL., INC. 185 OVAL DR. Central Islip, NY 11722 |
| Contact | Ernest Bohn |
| Correspondent | Ernest Bohn GAC INTL., INC. 185 OVAL DR. Central Islip, NY 11722 |
| Product Code | EJF |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-26 |
| Decision Date | 1993-09-13 |