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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K162044
Device Name Dentca Denture Base II
Applicant
Dentca, Inc.
357 Van Ness Way #250
Torrance,  CA  90501
Applicant Contact Jason Lee
Correspondent
Denterprise International, Inc.
100 E Granada Blvd.
Suite 219
Ormond Beach,  FL  32176
Correspondent Contact Claude Berthoin
Regulation Number872.3760
Classification Product Code
EBI  
Date Received07/25/2016
Decision Date 03/03/2017
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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