UNIFAST III


Device Classification Name

crown and bridge, temporary, resin

510(k) Number K073106
Device Name UNIFAST III
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 872.3770
Classification Product Code
EBG  
Subsequent Product Code
EBI  
Date Received 11/02/2007
Decision Date 04/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No