CLEARFIL SA CEMENT

Cement, Dental

KURARAY MEDICAL INC.

The following data is part of a premarket notification filed by Kuraray Medical Inc. with the FDA for Clearfil Sa Cement.

Pre-market Notification Details

Device IDK081583
510k NumberK081583
Device Name:CLEARFIL SA CEMENT
ClassificationCement, Dental
Applicant KURARAY MEDICAL INC. 600 LEXINGTON AVENUE 26TH FLOOR New York,  NY  10022
ContactKoji Nishida
CorrespondentKoji Nishida
KURARAY MEDICAL INC. 600 LEXINGTON AVENUE 26TH FLOOR New York,  NY  10022
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-06-05
Decision Date2008-07-28
Summary:summary

Trademark Results [CLEARFIL SA CEMENT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CLEARFIL SA CEMENT
CLEARFIL SA CEMENT
76680078 3526144 Dead/Cancelled
KURARAY CO., LTD.
2007-07-30

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