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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
Applicant
SHOFU DENTAL CORPORATION
1225 stone drive
san marcos,  CA  92078
Contact david p morais
Regulation Number872.3590
Classification Product Code
ELM  
Date Received06/14/2012
Decision Date 09/07/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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