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 |