510(k) K222961

Harvest Conceal ZR Block Out by Harvest Dental Products, LLC — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2023
Date Received
September 27, 2022
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