The following data is part of a premarket notification filed by Orthodontic Design And Production, Inc. with the FDA for Fastbraces Ceramic Brackets.
| Device ID | K130446 |
| 510k Number | K130446 |
| Device Name: | FASTBRACES CERAMIC BRACKETS |
| Classification | Bracket, Ceramic, Orthodontic |
| Applicant | ORTHODONTIC DESIGN AND PRODUCTION, INC. 1370 DECISION STREET SUITE D Vista, CA 92081 |
| Contact | Richard Merrell |
| Correspondent | Richard Merrell ORTHODONTIC DESIGN AND PRODUCTION, INC. 1370 DECISION STREET SUITE D Vista, CA 92081 |
| Product Code | NJM |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-21 |
| Decision Date | 2013-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860006117306 | K130446 | 000 |
| 00850048985261 | K130446 | 000 |
| 00850048985278 | K130446 | 000 |
| 00850048985285 | K130446 | 000 |
| 00850048985292 | K130446 | 000 |
| 00850048985308 | K130446 | 000 |
| 00850048985315 | K130446 | 000 |
| 00850048985322 | K130446 | 000 |
| 00850048985339 | K130446 | 000 |
| 00850048985346 | K130446 | 000 |
| 00850048985353 | K130446 | 000 |
| 00850048985049 | K130446 | 000 |