Crown And Bridge, Temporary, Resin

Quest Dental USA Corp.

The following data is part of a premarket notification filed by Quest Dental Usa Corp. with the FDA for Pure Pmma Disc.

Pre-market Notification Details

Device IDK201563
510k NumberK201563
Device Name:PuRE PMMA Disc
ClassificationCrown And Bridge, Temporary, Resin
Applicant Quest Dental USA Corp. 17865 Sky Park Circle, Suite L1 Irvine,  CA  92614
ContactHirotaka Mori
CorrespondentTakahiro Haruyama
Globizz Corporation 1411 W. 190th Street Suite 200 Gardena,  CA  90248
Product CodeEBG  
CFR Regulation Number872.3770 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-10
Decision Date2021-04-09

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