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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 K042905
Device Name NEO-CLIP ORTHODONTIC BRACKET ACCESSORY
Applicant
DENTSPLY INTL.
221 WEST PHILADELPHIA STREET
SUITE 60
YORK,  PA  17404
Applicant Contact HELEN LEWIS
Correspondent
DENTSPLY INTL.
221 WEST PHILADELPHIA STREET
SUITE 60
YORK,  PA  17404
Correspondent Contact HELEN LEWIS
Regulation Number872.5470
Classification Product Code
NJM  
Date Received10/21/2004
Decision Date 11/04/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Special
Reviewed by Third Party No
Combination Product No
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