DREAMBOND


Device Classification Name

agent, tooth bonding, resin

510(k) Number K112118
Device Name DREAMBOND
Applicant
BISCO, INC.
1100 west irving park rd.
schaumburg, 
IL 
60193

Applicant Contact michelle schiltz-taing
Correspondent
BISCO, INC.
1100 west irving park rd.
schaumburg, 
IL 
60193

Correspodent Contact michelle schiltz-taing
Regulation Number 872.3200
Classification Product Code
KLE  
Date Received 07/25/2011
Decision Date 11/17/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No