CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK


Device Classification Name

agent, tooth bonding, resin

510(k) Number K111975
Device Name CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK
Applicant
KURARAY MEDICAL INC.
ote center bld
7f, 1-1-3, otemachi
chiyoda-ku, tokyo, 

JP

100-0004

Applicant Contact michio takigawa
Correspondent
KURARAY MEDICAL INC.
ote center bld
7f, 1-1-3, otemachi
chiyoda-ku, tokyo, 

JP

100-0004

Correspodent Contact michio takigawa
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