The following data is part of a premarket notification filed by Quest Dental Usa Corp. with the FDA for Pure Pmma Disc.
| Device ID | K201563 |
| 510k Number | K201563 |
| Device Name: | PuRE PMMA Disc |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | Quest Dental USA Corp. 17865 Sky Park Circle, Suite L1 Irvine, CA 92614 |
| Contact | Hirotaka Mori |
| Correspondent | Takahiro Haruyama Globizz Corporation 1411 W. 190th Street Suite 200 Gardena, CA 90248 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-10 |
| Decision Date | 2021-04-09 |