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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin
510(k) Number K061252
Device Name PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM
Applicant
Primus Consulting
7046 Owl'S Nest Ter.
Bradenton,  FL  34023
Applicant Contact CAROLYN M PRIMUS
Correspondent
Primus Consulting
7046 Owl'S Nest Ter.
Bradenton,  FL  34023
Correspondent Contact CAROLYN M PRIMUS
Regulation Number872.3750
Classification Product Code
DYH  
Date Received05/04/2006
Decision Date 02/12/2007
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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