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 |