GRADIA FORTE


Device Classification Name

material, tooth shade, resin

510(k) Number K080478
Device Name GRADIA FORTE
Applicant
GC AMERICA, INC.
3737 west 127th st.
alsip, 
IL 
60803

Applicant Contact mark heiss
Correspondent
GC AMERICA, INC.
3737 west 127th st.
alsip, 
IL 
60803

Correspodent Contact mark heiss
Regulation Number 872.3690
Classification Product Code
EBF  
Date Received 02/22/2008
Decision Date 06/05/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No