510(k) K201683

PMMA Block by Huge Dental Material Co., Ltd. — Product Code EBG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 2020
Date Received
June 22, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Crown And Bridge, Temporary, Resin
Device Class
Class II
Regulation Number
872.3770
Review Panel
DE
Submission Type