The following data is part of a premarket notification filed by Gac Intl., Inc. with the FDA for Sentinol -orthodontic Arch Wire.
| Device ID | K851055 |
| 510k Number | K851055 |
| Device Name: | SENTINOL -ORTHODONTIC ARCH WIRE |
| Classification | Wire, Orthodontic |
| Applicant | GAC INTL., INC. 71 MALL DR. Commack, NY 11725 |
| Contact | Leo A Dohn |
| Correspondent | Leo A Dohn GAC INTL., INC. 71 MALL DR. Commack, NY 11725 |
| Product Code | DZC |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-14 |
| Decision Date | 1985-05-09 |