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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 K113197
Device Name APC FLASH-FREE ADHESIVE
Applicant
3M Unitek Corporation
2724 S. Peck Rd.
Monrovia,  CA  91016
Applicant Contact ROBERT WANG
Correspondent
3M Unitek Corporation
2724 S. Peck Rd.
Monrovia,  CA  91016
Correspondent Contact ROBERT WANG
Regulation Number872.3750
Classification Product Code
DYH  
Subsequent Product Codes
EJF   NJM  
Date Received10/31/2011
Decision Date 02/02/2012
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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