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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 K040375
Device Name IDEAL 1 ORTHODONTIC BAND CEMENT
Applicant
Dentsply Intl.
221 W. Philadelphia St., Suite 60
York,  PA  17404
Applicant Contact P. JEFFERY LEHN
Correspondent
Dentsply Intl.
221 W. Philadelphia St., Suite 60
York,  PA  17404
Correspondent Contact P. JEFFERY LEHN
Regulation Number872.3750
Classification Product Code
DYH  
Date Received02/17/2004
Decision Date 04/02/2004
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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