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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Varnish, Cavity
510(k) Number K994181
Device Name PULPDENT CAVITY PREPARATION II, PULPDENT CAVITY PREPARATION II WUTH FLUORIDE
Applicant
Pulpdent Corp.
80 Oakland St.
P.O. Box 780
Watertown,  MA  02471
Applicant Contact KENNETH J BERK
Correspondent
Pulpdent Corp.
80 Oakland St.
P.O. Box 780
Watertown,  MA  02471
Correspondent Contact KENNETH J BERK
Regulation Number872.3260
Classification Product Code
LBH  
Date Received12/10/1999
Decision Date 02/29/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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