510(k) K211854

VITA Akzent LC by Vita Zahnfabrik GmbH H Rauter & CO — Product Code EBD

K211854 is an FDA 510(k) premarket notification submitted by Vita Zahnfabrik GmbH H Rauter & CO for the device "VITA Akzent LC". The FDA issued a decision of Substantially Equivalent on November 22, 2021. The device falls under product code EBD (Coating, Filling Material, Resin), a Class II device regulated under 21 CFR 872.3310. Vita Zahnfabrik GmbH H Rauter & CO has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2021
Date Received
June 16, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coating, Filling Material, Resin
Device Class
Class II
Regulation Number
872.3310
Review Panel
DE
Submission Type