CLEARFIL SILANE KIT


Device Classification Name

agent, tooth bonding, resin

510(k) Number K024356
Device Name CLEARFIL SILANE KIT
Original Applicant
KURARAY MEDICAL INC.
101 east 52nd street, 26th fl.
new york, 
NY 
10022

Original Contact masaya sasaki
Regulation Number 872.3200
Classification Product Code
KLE  
Date Received 12/30/2002
Decision Date 03/26/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No