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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
Applicant Contact KENNETH J BERK
Correspondent
Pulpdent Corporation
80 Oakland St.
Watertown,  MA  02472
Correspondent Contact KENNETH J BERK
Regulation Number872.3770
Classification Product Code
EBG  
Date Received03/15/2012
Decision Date 06/08/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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