CLEARFIL AP-X PLT


Device Classification Name

material, tooth shade, resin

510(k) Number K023002
Device Name CLEARFIL AP-X PLT
Original Applicant
KURARAY MEDICAL INC.
101 east 52nd street, 26th fl.
new york, 
NY 
10022

Original Contact masaya sasaki
Regulation Number 872.3690
Classification Product Code
EBF  
Date Received 09/09/2002
Decision Date 10/25/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No