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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K210412
Device Name Pac-Dent Ceramic Nanohybrid Resin
Applicant
Pac-Dent, Inc.
670 Endeavor Cir.
Brea,  CA  92821
Applicant Contact Jingtian Peng
Correspondent
Pac-Dent, Inc.
670 Endeavor Cir.
Brea,  CA  92821
Correspondent Contact Jingtian Peng
Regulation Number872.3690
Classification Product Code
EBF  
Date Received02/11/2021
Decision Date 07/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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