TESCERA FIBER BUNDLES, FIBER MESH AND FIBER CYLINDERS

Device Classification Name

resin, denture, relining, repairing, rebasing

510(k) Number K034024
Device Name TESCERA FIBER BUNDLES, FIBER MESH AND FIBER CYLINDERS
Applicant
BISCO, INC.
1100 west irving park rd.
schaumburg, 
IL 
60193

Applicant Contact benjamin lichtenwalner
Correspondent
BISCO, INC.
1100 west irving park rd.
schaumburg, 
IL 
60193

Correspodent Contact benjamin lichtenwalner
Regulation Number 872.3760
Classification Product Code
EBI  
Date Received 12/29/2003
Decision Date 03/19/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No