The following data is part of a premarket notification filed by Clearcorrect, Inc. with the FDA for Clearcorrect System.
| Device ID | K113618 |
| 510k Number | K113618 |
| Device Name: | CLEARCORRECT SYSTEM |
| Classification | Aligner, Sequential |
| Applicant | CLEARCORRECT, INC. 611 W. 5TH STREET THIRD FLOOR Austin, TX 78701 |
| Contact | Cheryl Fisher |
| Correspondent | Cheryl Fisher CLEARCORRECT, INC. 611 W. 5TH STREET THIRD FLOOR Austin, TX 78701 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-07 |
| Decision Date | 2012-03-19 |
| Summary: | summary |