The following data is part of a premarket notification filed by Cdb Corporation with the FDA for Clear-aligners.
| Device ID | K191823 |
| 510k Number | K191823 |
| Device Name: | Clear-Aligners |
| Classification | Aligner, Sequential |
| Applicant | CDB Corporation 9201 Industrial Blvd Leland, NC 28451 |
| Contact | Leah M. Lehman |
| Correspondent | Leah M. Lehman CDB Corporation 9201 Industrial Blvd Leland, NC 28451 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-08 |
| Decision Date | 2019-12-20 |