GRADIA DIRECT


Device Classification Name

material, tooth shade, resin

510(k) Number K023814
Device Name GRADIA DIRECT
Original Applicant
GC AMERICA, INC.
3737 west 127th st.
alsip, 
IL 
60803

Original Contact terry l joritz
Regulation Number 872.3690
Classification Product Code
EBF  
Date Received 11/15/2002
Decision Date 01/30/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No