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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 K043573
Device Name DYNAGRAFT II DENTAL
Applicant
ISOTIS ORTHOBIOLOGICS, INC
2 GOODYEAR, SUITE B
IRVINE,  CA  92618
Applicant Contact PAUL DONER
Correspondent
ISOTIS ORTHOBIOLOGICS, INC
2 GOODYEAR, SUITE B
IRVINE,  CA  92618
Correspondent Contact PAUL DONER
Regulation Number872.3930
Classification Product Code
NUN  
Date Received12/27/2004
Decision Date 07/29/2005
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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