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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bone grafting material, human source
510(k) Number K103699
Device Name EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC
Applicant
EXACTECH, INC.
2320 N.W. 66TH CT.
GAINESVILLE,  FL  32653
Applicant Contact SHING JEN TAI, PHD
Correspondent
EXACTECH, INC.
2320 N.W. 66TH CT.
GAINESVILLE,  FL  32653
Correspondent Contact SHING JEN TAI, PHD
Regulation Number872.3930
Classification Product Code
NUN  
Date Received12/20/2010
Decision Date 08/12/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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