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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 K143033
Device Name DENTCA DENTURE BASE
Applicant
Dentca, Inc.
3608 Griffith Ave.
Los Angeles,  CA  90011
Applicant Contact Jason Lee
Correspondent
Denterprise International, Inc.
110 E. Granada Blvd., Suite 207
Ormond Beach,  FL  32176
Correspondent Contact CLAUDE BERTHOIN
Regulation Number872.3760
Classification Product Code
EBI  
Date Received10/22/2014
Decision Date 07/21/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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