FIT CHECKER ADVANCED


Device Classification Name

material, impression

510(k) Number K110871
Device Name FIT CHECKER ADVANCED
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 872.3660
Classification Product Code
ELW  
Date Received 03/29/2011
Decision Date 06/17/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No