CLEARFIL TRI-S BOND PLUS


Device Classification Name

agent, tooth bonding, resin

510(k) Number K111980
Device Name CLEARFIL TRI-S BOND PLUS
Applicant
KURARAY AMERICA, INC.
600 lexington ave.
26th floor
new york, 
NY 
10022

Applicant Contact kiyoyuki arikawa
Correspondent
KURARAY AMERICA, INC.
600 lexington ave.
26th floor
new york, 
NY 
10022

Correspodent Contact kiyoyuki arikawa
Regulation Number 872.3200
Classification Product Code
KLE  
Date Received 07/12/2011
Decision Date 10/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No