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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 K261474
Device Name DENTCA Tru Flexible
Applicant
Dentca, Inc.
17742 Cowan
Irvine,  CA  92614
Applicant Contact Jason Lee
Correspondent
Dentca, Inc.
17742 Cowan
Irvine,  CA  92614
Correspondent Contact Jason Lee
Regulation Number872.3760
Classification Product Code
EBI  
Date Received05/04/2026
Decision Date 07/01/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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