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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 K950991
Device Name DYRACT II RESTORATIVE
Applicant
Dentsply Intl.
570 W. College Ave.
P.O. Box 872
York,  PA  17405
Applicant Contact P. J LEHN
Correspondent
Dentsply Intl.
570 W. College Ave.
P.O. Box 872
York,  PA  17405
Correspondent Contact P. J LEHN
Regulation Number872.3690
Classification Product Code
EBF  
Date Received03/03/1995
Decision Date 03/23/1995
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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