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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 K062305
Device Name CLARITY MODIFIED CERAMIC BRACKETS
Applicant
3M UNITEK
2724 SOUTH PECK RD.
MONROVIA,  CA  91016
Applicant Contact L MARLYN SCHEFF
Correspondent
3M UNITEK
2724 SOUTH PECK RD.
MONROVIA,  CA  91016
Correspondent Contact L MARLYN SCHEFF
Regulation Number872.5470
Classification Product Code
NJM  
Date Received08/08/2006
Decision Date 10/18/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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