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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
FOIA Releasable 510(k) K102803
Device Name CLARITY ADVANCED CERAMIC BRACKETS
Applicant
3M Unitek Corporation
2724 S. Peck Rd.
Monrovia,  CA  91016
Applicant Contact MARLYN L SCHEFF
Correspondent
3M Unitek Corporation
2724 S. Peck Rd.
Monrovia,  CA  91016
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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