The following data is part of a premarket notification filed by Denmat Holdings, Llc with the FDA for Denmat Orthodontic Aligners.
| Device ID | K192470 |
| 510k Number | K192470 |
| Device Name: | DenMat Orthodontic Aligners |
| Classification | Aligner, Sequential |
| Applicant | DenMat Holdings, LLC 1017 W. Central Avenue Lompoc, CA 93436 |
| Contact | Tom Juarez |
| Correspondent | Prithul Bom 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 | 2019-09-09 |
| Decision Date | 2019-12-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D8130561004250 | K192470 | 000 |
| D8130561004000 | K192470 | 000 |
| D8130561003750 | K192470 | 000 |
| D8130562005350 | K192470 | 000 |
| D8130562005300 | K192470 | 000 |
| D8130561006970 | K192470 | 000 |