CLEARFIL AP-X PLT INTRO KIT


Device Classification Name

material, tooth shade, resin

510(k) Number K022999
Device Name CLEARFIL AP-X PLT INTRO KIT
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 10/24/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No