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510(k) K201563

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 2021
Date Received
June 10, 2020
Clearance Type
Special
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

Other clearances by Quest Dental USA Corp.

  • K172281 — PuRE PMMA Disc (October 19, 2017)

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