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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K130223
FOIA Releasable 510(k) K130223
Device Name RMGI FILL
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 Number872.3275
Classification Product Code
EMA  
Date Received01/29/2013
Decision Date 03/29/2013
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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