SURFACE COAT™

GUDID EKUR000263KA1

KURARAY NORITAKE DENTAL INC.

Dental unfilled resin sealant/coating Dental unfilled resin sealant/coating Dental unfilled resin sealant/coating Dental unfilled resin sealant/coating Dental unfilled resin sealant/coating Dental unfilled resin sealant/coating Dental unfilled resin sealant/coating Dental unfilled resin sealant/coating Dental unfilled resin sealant/coating
Primary Device IDEKUR000263KA1
NIH Device Record Keycb6039d4-4515-4205-8439-5a333e8d5e3f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSURFACE COAT™
Version Model Number#263-KA
Company DUNS697119498
Company NameKURARAY NORITAKE DENTAL INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEKUR000263KA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBDCoating, Filling Material, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-02-17

Devices Manufactured by KURARAY NORITAKE DENTAL INC.

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EKUR1259732KA0 - KATANA™ Zirconia ONE2024-04-08 SPEED CROWN A3
EKUR1259733KA0 - KATANA™ Zirconia ONE2024-04-08 SPEED CROWN A3.5
EKUR1259734KA0 - KATANA™ Zirconia ONE2024-04-08 SPEED CROWN A4
EKUR1259735KA0 - KATANA™ Zirconia ONE2024-04-08 SPEED CROWN B1
EKUR1259736KA0 - KATANA™ Zirconia ONE2024-04-08 SPEED CROWN B2
EKUR1259737KA0 - KATANA™ Zirconia ONE2024-04-08 SPEED CROWN B3

Trademark Results [SURFACE COAT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SURFACE COAT
SURFACE COAT
76654419 3266507 Live/Registered
KURARAY CO., LTD.
2006-02-01

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