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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression Tray, Resin
510(k) Number K854042
Device Name RESIN TRAY IMPRESSION MATERIAL
Applicant
Dentsply Intl.
570 W. College Ave.
P.O. Box 872
York,  PA  17405
Applicant Contact JOHN SEMMELMAN
Correspondent
Dentsply Intl.
570 W. College Ave.
P.O. Box 872
York,  PA  17405
Correspondent Contact JOHN SEMMELMAN
Regulation Number872.3670
Classification Product Code
EBH  
Date Received10/02/1985
Decision Date 11/07/1985
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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