KURARAY NORITAKE DENTAL INC.

Address:300 HIGASHIYAMA,MIYOSHI Aichi,JP

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Material, Tooth Shade, Resin (EBF) (6) Sealant, Pit And Fissure, And Conditioner (EBC) (4)

Premarket Exempt

Clear

CLEARFIL™ AP-X PLT - EKUR001744KA1 Catalog Number :

Device Description : A4

Device Class :

Duns Number: 697119498

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 20

CLEARFIL™ AP-X PLT - EKUR001745KA1 Catalog Number :

Device Description : B2

Device Class :

Duns Number: 697119498

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 20

CLEARFIL™ AP-X PLT - EKUR001746KA1 Catalog Number :

Device Description : B3

Device Class :

Duns Number: 697119498

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 20

CLEARFIL™ AP-X PLT - EKUR001751KA1 Catalog Number :

Device Description : XL

Device Class :

Duns Number: 697119498

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 20

CLEARFIL™ AP-X PLT - EKUR001754KA1 Catalog Number :

Device Description : HO

Device Class :

Duns Number: 697119498

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 20

CLEARFIL™ AP-X PLT - EKUR001755KA1 Catalog Number :

Device Description : A2 (Sample)

Device Class :

Duns Number: 697119498

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 10

TEETHMATE™ F-1 - EKUR001760KA1 Catalog Number :

Device Description : Kit (Natural)

Device Class : 2

Duns Number: 697119498

Premarket Exempt : No

Product Code : EBC

Prescription Use : Yes

Device Count : 1

TEETHMATE™ F-1 - EKUR001765KA1 Catalog Number :

Device Description : Natural

Device Class : 2

Duns Number: 697119498

Premarket Exempt : No

Product Code : EBC

Prescription Use : Yes

Device Count : 1

TEETHMATE™ F-1 - EKUR001790KA1 Catalog Number :

Device Description : Kit (Opaque)

Device Class : 2

Duns Number: 697119498

Premarket Exempt : No

Product Code : EBC

Prescription Use : Yes

Device Count : 1

TEETHMATE™ F-1 - EKUR001795KA1 Catalog Number :

Device Description : Opaque

Device Class : 2

Duns Number: 697119498

Premarket Exempt : No

Product Code : EBC

Prescription Use : Yes

Device Count : 1

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