510(k) K210504

PANAVIA Veneer LC by Kuraray Noritake Dental, Inc. — Product Code EMA

K210504 is an FDA 510(k) premarket notification submitted by Kuraray Noritake Dental, Inc. for the device "PANAVIA Veneer LC". The FDA issued a decision of Substantially Equivalent on June 11, 2021. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Kuraray Noritake Dental, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2021
Date Received
February 22, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Dental
Device Class
Class II
Regulation Number
872.3275
Review Panel
DE
Submission Type