ACRON MC MODIFICATION


Device Classification Name

resin, denture, relining, repairing, rebasing

510(k) Number K991774
Device Name ACRON MC MODIFICATION
Applicant
GC AMERICA, INC.
3737 west 127th st.
alsip, 
IL 
60803

Applicant Contact terry l joritz
Correspondent
GC AMERICA, INC.
3737 west 127th st.
alsip, 
IL 
60803

Correspodent Contact terry l joritz
Regulation Number 872.3760
Classification Product Code
EBI  
Date Received 05/25/1999
Decision Date 07/09/1999
Decision

substantially equivalent

(SESE)
Regulation Medical Specialty

Dental

510k Review Panel

Dental
statement

statement

Type Traditional
Reviewed by Third Party No
Combination Product

No