The following data is part of a premarket notification filed by 3dbiocad with the FDA for Purzir Dental Zirconia.
| Device ID | K193055 |
| 510k Number | K193055 |
| Device Name: | Purzir Dental Zirconia |
| Classification | Powder, Porcelain |
| Applicant | 3DBioCAD 1525 N 4th St. Renton, WA 98057 |
| Contact | Gyu D. Cho |
| Correspondent | Stuart R. Goldman EMERGO Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-01 |
| Decision Date | 2020-05-13 |