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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name crown and bridge, temporary, resin
510(K) Number K120784
Device Name TUFF-TEMP 2.0
Applicant
PULPDENT CORPORATION
80 oakland st
watertown,  MA  02472
Contact kenneth j berk
Regulation Number872.3770
Classification Product Code
EBG  
Date Received03/15/2012
Decision Date 06/08/2012
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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