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

Agent, Tooth Bonding, Resin (KLE) (10) Coating, Filling Material, Resin (EBD) (1) Material, Tooth Shade, Resin (EBF) (1)

Premarket Exempt

Clear

CLEARFIL™ LINER BOND 2V - EKUR001921KA1 Catalog Number :

Device Description : DC Kit

Device Class : 2

Duns Number: 697119498

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

CLEARFIL™ LINER BOND 2V - EKUR001930KA1 Catalog Number :

Device Description : BOND Liquid A

Device Class : 2

Duns Number: 697119498

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

CLEARFIL™ LINER BOND 2V - EKUR001931KA1 Catalog Number :

Device Description : BOND Liquid B

Device Class : 2

Duns Number: 697119498

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

CLEARFIL™ LINER BOND 2V - EKUR001943KA1 Catalog Number :

Device Description : PRIMER Liquid A

Device Class : 2

Duns Number: 697119498

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

CLEARFIL™ LINER BOND 2V - EKUR001944KA1 Catalog Number :

Device Description : PRIMER Liquid B

Device Class : 2

Duns Number: 697119498

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

CLEARFIL™ SE BOND - EKUR001970KA1 Catalog Number :

Device Description : Kit

Device Class : 2

Duns Number: 697119498

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

CLEARFIL™ SE BOND - EKUR001972KA1 Catalog Number :

Device Description : Value Kit

Device Class :

Duns Number: 697119498

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 3

CLEARFIL™ REPAIR Multi Purpose - EKUR001973KA1 Catalog Number :

Device Class : 2

Duns Number: 697119498

Premarket Exempt : No

Product Code : KLE, EBF, EBD

Prescription Use : Yes

Device Count : 1

CLEARFIL™ SE BOND - EKUR001975KA1 Catalog Number :

Device Description : Introductory Kit

Device Class : 2

Duns Number: 697119498

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

CLEARFIL™ SE BOND - EKUR001981KA1 Catalog Number :

Device Description : BOND

Device Class : 2

Duns Number: 697119498

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

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