The following data is part of a premarket notification filed by Clearcorrect Llc with the FDA for Clearcorrect System.
| Device ID | K210320 |
| 510k Number | K210320 |
| Device Name: | ClearCorrect System |
| Classification | Aligner, Sequential |
| Applicant | ClearCorrect LLC 21 Cypress Boulevard, Suite 1010 Round Rock, TX 78665 |
| Contact | Christopher Klaczyk |
| Correspondent | Christopher Klaczyk ClearCorrect LLC 21 Cypress Boulevard, Suite 1010 Round Rock, TX 78665 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-04 |
| Decision Date | 2021-08-06 |