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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 K060332
Device Name ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY
Applicant
Isotis NV
Prof. Bronkhorstlaan 10-D
Bilthoven,  NL 3723MB
Applicant Contact ELIANE SCHUTTE
Correspondent
Isotis NV
Prof. Bronkhorstlaan 10-D
Bilthoven,  NL 3723MB
Correspondent Contact ELIANE SCHUTTE
Regulation Number872.3930
Classification Product Code
NUN  
Date Received02/09/2006
Decision Date 03/29/2006
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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