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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name additively manufactured, preformed, resin denture tooth
510(k) Number K172398
Device Name DENTCA DENTURE Teeth
Applicant
DENTCA, INC.
357 Van Ness Way, Suite 250
Torrance,  CA  90501
Applicant Contact Jason Lee
Correspondent
DENTERPRISE INTERNATIONAL, INC.
100 East Granada Blvd., Suite 219
Ormond Beach,  FL  32176
Correspondent Contact Joyce St. Germain
Regulation Number872.3590
Classification Product Code
PZY  
Date Received08/08/2017
Decision Date 11/22/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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