SCULPTING RESIN


Device Classification Name

coating, filling material, resin

510(k) Number K030585
Device Name SCULPTING RESIN
Applicant
BISCO, INC.
1100 west irving park rd.
schaumburg, 
IL 
60193

Applicant Contact stephen smith
Correspondent
BISCO, INC.
1100 west irving park rd.
schaumburg, 
IL 
60193

Correspodent Contact stephen smith
Regulation Number 872.3310
Classification Product Code
EBD  
Date Received 02/24/2003
Decision Date 04/28/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No