The following data is part of a premarket notification filed by Arcadlab with the FDA for Arcad Smilestudio And Aligner System.
| Device ID | K192244 |
| 510k Number | K192244 |
| Device Name: | Arcad SmileStudio And Aligner System |
| Classification | Aligner, Sequential |
| Applicant | ArcadLab 1860 Old Okeechobee Road, Suite 402 West Palm Beach, FL 33409 |
| Contact | Emerson Cano |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-19 |
| Decision Date | 2020-05-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860011071921 | K192244 | 000 |