The following data is part of a premarket notification filed by Derby Dental Laboratory with the FDA for Custom Clear Aligner System.
| Device ID | K173785 |
| 510k Number | K173785 |
| Device Name: | Custom Clear Aligner System |
| Classification | Aligner, Sequential |
| Applicant | Derby Dental Laboratory 3332 Gilmore Industrial Blvd Louisville, KY 40213 |
| Contact | Reed Nunnally |
| Correspondent | Patsy J Trisler Trisler Consulting 5600 Wisconsin Ave, #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 | 2017-12-13 |
| Decision Date | 2018-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860002302300 | K173785 | 000 |
| 00860002302348 | K173785 | 000 |
| 00860002302331 | K173785 | 000 |
| 00860002302317 | K173785 | 000 |
| 00817645020177 | K173785 | 000 |
| 00860002302355 | K173785 | 000 |