The following data is part of a premarket notification filed by Pac-dent, Inc. with the FDA for Pac-dent Denture Base Resin.
| Device ID | K210189 |
| 510k Number | K210189 |
| Device Name: | Pac-Dent Denture Base Resin |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| 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 | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-25 |
| Decision Date | 2021-07-28 |