510(k) K230487

Dental Lithium Disilicate Glass-Ceramic by Fuzhou Rick Brown Biomaterials Co., Ltd. — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2023
Date Received
February 23, 2023
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