The following data is part of a premarket notification filed by Vita Zahnfabrik H.rauter Gmbh Co. with the FDA for Vita Yz St And Vita Yz Xt.
Device ID | K180703 |
510k Number | K180703 |
Device Name: | VITA YZ ST And VITA YZ XT |
Classification | Powder, Porcelain |
Applicant | VITA Zahnfabrik H.Rauter GmbH Co. Spitelgasse 3 Bad Sackingen, DE D-79713 |
Contact | Bernd Walker |
Correspondent | Nevine Erian VITA North America 22705 Savi Ranch Parkway, Suite 100 Yorba Linda, CA 92887 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-03-19 |
Decision Date | 2018-08-01 |
Summary: | summary |