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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 K053374
Device Name OSSAPLAST DENTAL (PARTICLE SIZE OF 500 TO 1000 UM TO 2000 UM)
Applicant
Ossacur AG
975 Veronics Springs Rd.
Santa Barbara,  CA  93105
Applicant Contact KRISTI KISTNER
Correspondent
Ossacur AG
975 Veronics Springs Rd.
Santa Barbara,  CA  93105
Correspondent Contact KRISTI KISTNER
Regulation Number872.3930
Classification Product Code
LYC  
Date Received12/05/2005
Decision Date 02/21/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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