MODIFICATION TO CLEARFIL SE BOND

Agent, Tooth Bonding, Resin

KURARAY MEDICAL INC.

The following data is part of a premarket notification filed by Kuraray Medical Inc. with the FDA for Modification To Clearfil Se Bond.

Pre-market Notification Details

Device IDK012442
510k NumberK012442
Device Name:MODIFICATION TO CLEARFIL SE BOND
ClassificationAgent, Tooth Bonding, Resin
Applicant KURARAY MEDICAL INC. 30TH FL. METLIFE BUILDING 200 PARK AVENUE New York,  NY  10166
ContactMasaya Sasaki
CorrespondentMasaya Sasaki
KURARAY MEDICAL INC. 30TH FL. METLIFE BUILDING 200 PARK AVENUE New York,  NY  10166
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-07-31
Decision Date2001-09-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
EKUR001982KA1 K012442 000
EKUR001981KA1 K012442 000
EKUR001975KA1 K012442 000
EKUR001972KA1 K012442 000
EKUR001970KA1 K012442 000

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