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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 K102803
Device Name CLARITY ADVANCED CERAMIC BRACKETS
Original Applicant
3M UNITEK CORPORATION
2724 south peck rd.
monrovia,  CA  91016
Original Contact marlyn l scheff
Regulation Number872.5470
Classification Product Code
NJM  
Date Received09/28/2010
Decision Date 02/17/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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