GC MODELS OPA-100 AND JC-50


Device Classification Name

adhesive, bracket and tooth conditioner, resin

510(k) Number K073588
Device Name GC MODELS OPA-100 AND JC-50
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 872.3750
Classification Product Code
DYH  
Date Received 12/20/2007
Decision Date 02/15/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Traditional
Reviewed by Third Party No

Combination Product

Yes