The following data is part of a premarket notification filed by Star Dentech Korea., Corp with the FDA for Orthodontic Ceramic Bracket.
| Device ID | K090567 |
| 510k Number | K090567 |
| Device Name: | ORTHODONTIC CERAMIC BRACKET |
| Classification | Bracket, Ceramic, Orthodontic |
| Applicant | STAR DENTECH KOREA., CORP 49 CANDLEWOOD WAY Buena Park, CA 90621 |
| Contact | Brandon Choi |
| Correspondent | Brandon Choi STAR DENTECH KOREA., CORP 49 CANDLEWOOD WAY Buena Park, CA 90621 |
| Product Code | NJM |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-03 |
| Decision Date | 2009-05-27 |
| Summary: | summary |