The following data is part of a premarket notification filed by Cdb Corporation with the FDA for Hit Clear Aligner.
| Device ID | K210613 |
| 510k Number | K210613 |
| Device Name: | HIT Clear Aligner |
| Classification | Aligner, Sequential |
| Applicant | CDB Corporation 9201 Industrial Park Boulevard Leland, NC 28451 |
| Contact | Leah M Lehman |
| Correspondent | Leah M Lehman CDB Corporation 9201 Industrial Boulevard, NE Leland, NC 28451 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-01 |
| Decision Date | 2021-06-04 |