PuRE PMMA Disc— 510(k) K172281

Substantially Equivalent

Quest Dental USA Corp.

FDA 510(k) clearance K172281 for PuRE PMMA Disc, Substantially Equivalent on 2017-10-19. Applicant: Quest Dental USA Corp.. Device class: 2.

Clearance details

Applicant
Quest Dental USA Corp.
Product code
Code EBG
Device class
Class 2
Regulation
21 CFR 872.3770
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Irvine, CA, US
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