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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 K042706
Device Name OSSATURA 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
LYC  
Date Received09/30/2004
Decision Date 10/20/2004
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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