The following data is part of a premarket notification filed by Tomy, Inc with the FDA for Orthodontic Ceramic Brackets 1.1.
| Device ID | K160615 |
| 510k Number | K160615 |
| Device Name: | ORTHODONTIC CERAMIC BRACKETS 1.1 |
| Classification | Bracket, Ceramic, Orthodontic |
| Applicant | TOMY, INC 6 TENKO BLG. 3-16-7 Midoricho, Fuchu City, JP 183-0006 |
| Contact | Jinichi Watanabe |
| Correspondent | Carolyn Primus PRIMUS CONSULTING 7046 OWLS NEST TERR Bradenton, FL 34203 |
| Product Code | NJM |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-03 |
| Decision Date | 2016-08-26 |
| Summary: | summary |