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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 K100671
Device Name NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT
Applicant
Novabone Products, LLC
13631 Progress Blvd.
Suite 600
Alachua,  FL  32615
Applicant Contact DAVID M GAISSER
Correspondent
Novabone Products, LLC
13631 Progress Blvd.
Suite 600
Alachua,  FL  32615
Correspondent Contact DAVID M GAISSER
Regulation Number872.3930
Classification Product Code
LYC  
Date Received03/09/2010
Decision Date 03/30/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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