OSTIM


Device Classification Name

bone grafting material, synthetic

510(k) Number K030052
Device Name OSTIM
Original Applicant
HERAEUS KULZER, INC.
4315 south lafayette blvd.
south bend, 
IN 
46614 -2517

Original Contact cheryl v zimmerman
Regulation Number 872.3930
Classification Product Code
LYC  
Date Received 01/06/2003
Decision Date 12/06/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No