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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K942031
Device Name CAULK TOOTH CONDITIONER GEL AND SYRINGE
Applicant
Dentsply Intl.
570 W. College Ave.
P.O. Box 872
York,  PA  17405
Applicant Contact P. JEFFREY LEHN
Correspondent
Dentsply Intl.
570 W. College Ave.
P.O. Box 872
York,  PA  17405
Correspondent Contact P. JEFFREY LEHN
Regulation Number872.3690
Classification Product Code
EBF  
Date Received04/26/1994
Decision Date 06/10/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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