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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
Applicant
3M UNITEK CORPORATION
2724 south peck rd.
monrovia,  CA  91016
Contact marlyn l scheff
Regulation Number872.5470
Classification Product Code
NJM  
Date Received09/28/2010
Decision Date 02/17/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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