The following data is part of a premarket notification filed by Tomy, Inc. with the FDA for Ceramin Brackets Z.
| Device ID | K123092 |
| 510k Number | K123092 |
| Device Name: | CERAMIN BRACKETS Z |
| Classification | Bracket, Ceramic, Orthodontic |
| Applicant | TOMY, INC. 7046 OWL'S NEST TERRACE Bradenton, FL 34203 |
| Contact | Carolyn Primus |
| Correspondent | Carolyn Primus TOMY, INC. 7046 OWL'S NEST TERRACE 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 | 2012-10-02 |
| Decision Date | 2012-12-21 |
| Summary: | summary |