The following data is part of a premarket notification filed by Creodent Prosthetics Ltd with the FDA for Creokorrekt Aligners.
| Device ID | K211427 |
| 510k Number | K211427 |
| Device Name: | CREOKORREKT Aligners |
| Classification | Aligner, Sequential |
| Applicant | CreoDent Prosthetics LTD 515 West 45th Street 11FL New York, NY 10036 |
| Contact | Calvin Shim |
| Correspondent | April Lee Withus Group Inc. 106 Superior Irvine, CA 92620 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-07 |
| Decision Date | 2022-10-13 |