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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, synthetic
510(k) Number K111105
Device Name CURASAN OSSEOLIVE DENTAL
Applicant
CURASAN AG
PIAZZA ALBANIA 10
ROME,  IT 00153
Applicant Contact ROGER GRAY
Correspondent
CURASAN AG
PIAZZA ALBANIA 10
ROME,  IT 00153
Correspondent Contact ROGER GRAY
Regulation Number872.3930
Classification Product Code
LYC  
Date Received04/20/2011
Decision Date 12/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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