510(k) K172281

PuRE PMMA Disc by Quest Dental USA Corp. — Product Code EBG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2017
Date Received
July 28, 2017
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