510(k) K180703

VITA YZ ST and VITA YZ XT by Vita Zahnfabrik H.Rauter GmbH Co. — Product Code EIH

K180703 is an FDA 510(k) premarket notification submitted by Vita Zahnfabrik H.Rauter GmbH Co. for the device "VITA YZ ST and VITA YZ XT". The FDA issued a decision of Substantially Equivalent on Aug 1, 2018. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Vita Zahnfabrik H.Rauter GmbH Co. has 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 1, 2018
Date Received
Mar 19, 2018
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Powder, Porcelain
Device Class
Class II
Regulation Number
872.6660
Review Panel
DE
Submission Type
510(k)