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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin
510(k) Number K033703
Device Name IDEAL 1 ORTHODONTIC BRACKET ADHESIVE
Applicant
Dentsply Intl.
570 W. College Ave.
P.O. Box 872
York,  PA  17405 -0872
Applicant Contact P. JEFFERY LEHN
Correspondent
Dentsply Intl.
570 W. College Ave.
P.O. Box 872
York,  PA  17405 -0872
Correspondent Contact P. JEFFERY LEHN
Regulation Number872.3750
Classification Product Code
DYH  
Date Received11/25/2003
Decision Date 02/06/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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