NOVABONE DENTAL MORSELS – BIOACTIVE SYNTHETIC BONE GRAFT


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

Correspodent Contact david m gaisser
Regulation Number 872.3930
Classification Product Code
LYC  
Date Received 08/23/2011
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