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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name crown and bridge, temporary, resin
510(k) Number K201563
Device Name PuRE PMMA Disc
Applicant
Quest Dental USA Corp.
17865 Sky Park Circle, Suite L1
Irvine,  CA  92614
Applicant Contact Hirotaka Mori
Correspondent
Globizz Corporation
1411 W. 190th Street Suite 200
Gardena,  CA  90248
Correspondent Contact Takahiro Haruyama
Regulation Number872.3770
Classification Product Code
EBG  
Date Received06/10/2020
Decision Date 04/09/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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