BBP BONE SUBSTITUTES


Device Classification Name

bone grafting material, synthetic

510(k) Number K030195
Device Name BBP BONE SUBSTITUTES
Original Applicant
OCT, USA, INC.
13 red fox ln.
littleton, 
CO 
80127

Original Contact kevin walls
Regulation Number 872.3930
Classification Product Code
LYC  
Date Received 01/21/2003
Decision Date 06/17/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No