The following data is part of a premarket notification filed by Park Dental Research Corporation with the FDA for Park Dental Research Aligners.
| Device ID | K180648 |
| 510k Number | K180648 |
| Device Name: | Park Dental Research Aligners |
| Classification | Aligner, Sequential |
| Applicant | Park Dental Research Corporation 2401 N. Commerce St Suite E Ardmore, OK 73401 |
| Contact | Ronald A. Bulard |
| Correspondent | Angela Blackwell Blackwell Device Consulting P.O. Box 718 Gresham, OR 97030 -0172 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-13 |
| Decision Date | 2019-01-08 |