The following data is part of a premarket notification filed by 3m Unitek Corporation with the FDA for Clarity Advanced Ceramic Brackets.
| Device ID | K102803 |
| 510k Number | K102803 |
| Device Name: | CLARITY ADVANCED CERAMIC BRACKETS |
| Classification | Bracket, Ceramic, Orthodontic |
| Applicant | 3M UNITEK CORPORATION 2724 SOUTH PECK RD. Monrovia, CA 91016 |
| Contact | Marlyn L Scheff |
| Correspondent | Marlyn L Scheff 3M UNITEK CORPORATION 2724 SOUTH PECK RD. Monrovia, CA 91016 |
| Product Code | NJM |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-28 |
| Decision Date | 2011-02-17 |
| Summary: | summary |