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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown And Bridge, Temporary, Resin
510(k) Number K904251
Device Name NEW TRIAD VLC CROWN & BRIDGE PROVISIONAL MATERIAL
Applicant
Dentifax Intern, Inc.
570 W. College Ave.
P.O. Box 872
York,  PA  17405
Applicant Contact JEFFERY LEHN
Correspondent
Dentifax Intern, Inc.
570 W. College Ave.
P.O. Box 872
York,  PA  17405
Correspondent Contact JEFFERY LEHN
Regulation Number872.3770
Classification Product Code
EBG  
Date Received09/13/1990
Decision Date 06/06/1991
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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