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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bracket, ceramic, orthodontic
510(k) Number K042178
Device Name ORTHODONTIC CERAMIC BRACKETS
Applicant
DENTSPLY INTL.
221 WEST PHILADELPHIA STREET
SUITE 60
YORK,  PA  17404
Applicant Contact P. JEFFERY LEHN
Correspondent
DENTSPLY INTL.
221 WEST PHILADELPHIA STREET
SUITE 60
YORK,  PA  17404
Correspondent Contact P. JEFFERY LEHN
Regulation Number872.5470
Classification Product Code
NJM  
Date Received08/11/2004
Decision Date 08/30/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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