The following data is part of a premarket notification filed by Cdb Corporation with the FDA for Cdb Self Ligating Bracket 8f.
| Device ID | K160957 |
| 510k Number | K160957 |
| Device Name: | CDB Self Ligating Bracket 8F |
| Classification | Bracket, Ceramic, Orthodontic |
| Applicant | CDB CORPORATION 9201 INDUSTRIAL BOULEVARD, NE Leland, NC 28451 |
| Contact | Yannire Thompson |
| Correspondent | Yannire Thompson CDB CORPORATION 9201 INDUSTRIAL BOULEVARD, NE Leland, NC 28451 |
| Product Code | NJM |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-05 |
| Decision Date | 2016-09-27 |
| Summary: | summary |