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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name denture, plastic, teeth
510(k) Number K121749
Device Name VERACIA
Original Applicant
SHOFU DENTAL CORPORATION
1225 stone drive
san marcos,  CA  92078
Original Contact david p morais
Regulation Number872.3590
Classification Product Code
ELM  
Date Received06/14/2012
Decision Date 09/07/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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