TEMPORARY CEMENT-DC010002


Device Classification Name

cement, dental

510(k) Number K023727
Device Name TEMPORARY CEMENT-DC010002
Original Applicant
GC AMERICA, INC.
3737 west 127th st.
alsip, 
IL 
60803

Original Contact terry l joritz
Regulation Number 872.3275
Classification Product Code
EMA  
Date Received 11/06/2002
Decision Date 01/16/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No