The following data is part of a premarket notification filed by Pac-dent, Inc. with the FDA for Pac-dent Ceramic Nanohybrid Resin.
| Device ID | K210412 |
| 510k Number | K210412 |
| Device Name: | Pac-Dent Ceramic Nanohybrid Resin |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Pac-Dent, Inc. 670 Endeavor Circle Brea, CA 92821 |
| Contact | Jingtian Peng |
| Correspondent | Jingtian Peng Pac-Dent, Inc. 670 Endeavor Circle Brea, CA 92821 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-11 |
| Decision Date | 2021-07-26 |