The following data is part of a premarket notification filed by Specialty Appliance Works, Inc. with the FDA for Clear Image Aligners.
| Device ID | K183643 |
| 510k Number | K183643 |
| Device Name: | Clear Image Aligners |
| Classification | Aligner, Sequential |
| Applicant | Specialty Appliance Works, Inc. 4905 Hammond Industrial Drive Cumming, GA 30041 |
| Contact | Carolyn Thomas |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-12-26 |
| Decision Date | 2019-01-03 |
| Summary: | summary |