TOKUYAMA REBASE II


Device Classification Name

resin, denture, relining, repairing, rebasing

510(k) Number K022641
Device Name TOKUYAMA REBASE II
Original Applicant
TOKUYAMA AMERICA, INC.
2000 m st. nw
suite 700
washington, 
DC 
20036

Original Contact daniel j manelli
Regulation Number 872.3760
Classification Product Code
EBI  
Date Received 08/08/2002
Decision Date 10/02/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No