The following data is part of a premarket notification filed by Argen Corporation with the FDA for Argen Clear Aligner.
| Device ID | K183229 |
| 510k Number | K183229 |
| Device Name: | Argen Clear Aligner |
| Classification | Aligner, Sequential |
| Applicant | Argen Corporation 5855 Oberlin Drive San Diego, CA 92121 |
| Contact | Paul Cascone |
| Correspondent | Patsy J. Trisler Qserve Group US, Inc. 5600 Wisconsin Avenue, #509 Chevy Chase, MD 20815 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-20 |
| Decision Date | 2019-06-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D818127467 | K183229 | 000 |
| D818125300 | K183229 | 000 |