The following data is part of a premarket notification filed by Zirkonzahn Srl with the FDA for Color Liquid, Vita Liquid.
Device ID | K190518 |
510k Number | K190518 |
Device Name: | Color Liquid, Vita Liquid |
Classification | Powder, Porcelain |
Applicant | Zirkonzahn Srl Via An Der Ahr 7 Gais, IT 39030 |
Contact | Julian Steger |
Correspondent | Sandra Leitner Zirkonzahn Srl Via An Der Ahr 7 Gais, IT 39030 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-03-04 |
Decision Date | 2019-11-22 |