The following data is part of a premarket notification filed by Argen Corporation with the FDA for Argen Clear Aligner, Argen Clear Aligner Premium.
| Device ID | K192846 |
| 510k Number | K192846 |
| Device Name: | Argen Clear Aligner, Argen Clear Aligner Premium |
| Classification | Aligner, Sequential |
| Applicant | Argen Corporation 5855 Oberlin Drive San Diego, CA 92121 |
| Contact | Paul Cascone |
| Correspondent | Patsy J. Trisler Qserve Group US, Inc. 7949 Beaumont Green East Drive Indianapolis, IN 46250 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-03 |
| Decision Date | 2020-02-10 |