The following data is part of a premarket notification filed by Inman Orthodontic Laboratories, Inc. with the FDA for Inman Digital Clear Aligners.
| Device ID | K210763 |
| 510k Number | K210763 |
| Device Name: | Inman Digital Clear Aligners |
| Classification | Aligner, Sequential |
| Applicant | Inman Orthodontic Laboratories, Inc. 3953 NW 126th Avenue Coral Springs, FL 33065 |
| Contact | Donal P. Inman |
| Correspondent | Patsy J. Trisler Trisler Consulting 7949 Beaumont Green East Drive Indianapolis, IN 46250 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-15 |
| Decision Date | 2021-09-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| DCA253272 | K210763 | 000 |
| D141DCA2532729 | K210763 | 000 |