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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Liner, Cavity, Calcium Hydroxide
510(k) Number K922721
Device Name VLC DYCAL II
Applicant
Dentsply Intl.
570 W. College Ave.
P.O. Box 872
York,  PA  17405
Applicant Contact JEFFERY LEHN
Correspondent
Dentsply Intl.
570 W. College Ave.
P.O. Box 872
York,  PA  17405
Correspondent Contact JEFFERY LEHN
Regulation Number872.3250
Classification Product Code
EJK  
Date Received06/05/1992
Decision Date 07/23/1992
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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