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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 K112428
Device Name NOVABONE DENTAL MORSELS - 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 Received08/23/2011
Decision Date 12/16/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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