510(k) K243940

VITA YZ Multi Translucent by Vita Zahnfabrik H.Rauter GmbH & Co. — Product Code EIH

K243940 is an FDA 510(k) premarket notification submitted by Vita Zahnfabrik H.Rauter GmbH & Co. for the device "VITA YZ Multi Translucent". The FDA issued a decision of Substantially Equivalent on Feb 21, 2025. 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 at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 21, 2025
Date Received
Dec 20, 2024
Clearance Type
Traditional
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