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

Cement, Dental (EMA) (10) Agent, Tooth Bonding, Resin (KLE) (4) Material, Tooth Shade, Resin (EBF) (4)

Premarket Exempt

Clear

PANAVIA™ F 2.0 - EKUR000492KA1 Catalog Number :

Device Description : ED PRIMER Ⅱ Liquid B

Device Class : 2

Duns Number: 697119498

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

PANAVIA™ F 2.0 - EKUR000493KA1 Catalog Number :

Device Description : A paste

Device Class : 2

Duns Number: 697119498

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

PANAVIA™ F 2.0 - EKUR000494KA1 Catalog Number :

Device Description : B paste (TC)

Device Class : 2

Duns Number: 697119498

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

PANAVIA™ F 2.0 - EKUR000495KA1 Catalog Number :

Device Description : B paste (WHITE)

Device Class : 2

Duns Number: 697119498

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

PANAVIA™ F 2.0 - EKUR000496KA1 Catalog Number :

Device Description : B paste (OPAQUE)

Device Class : 2

Duns Number: 697119498

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

PANAVIA™ F 2.0 - EKUR000497KA1 Catalog Number :

Device Description : B paste (LIGHT)

Device Class : 2

Duns Number: 697119498

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

PANAVIA™ F 2.0 Complete Kit - EKUR000501KA1 Catalog Number :

Device Description : TC

Device Class : 2

Duns Number: 697119498

Premarket Exempt : No

Product Code : EBF, KLE, EMA

Prescription Use : Yes

Device Count : 1

PANAVIA™ F 2.0 Complete Kit - EKUR000502KA1 Catalog Number :

Device Description : WHITE

Device Class : 2

Duns Number: 697119498

Premarket Exempt : No

Product Code : EMA, KLE, EBF

Prescription Use : Yes

Device Count : 1

PANAVIA™ F 2.0 Complete Kit - EKUR000503KA1 Catalog Number :

Device Description : OPAQUE

Device Class : 2

Duns Number: 697119498

Premarket Exempt : No

Product Code : EBF, KLE, EMA

Prescription Use : Yes

Device Count : 1

PANAVIA™ F 2.0 Complete Kit - EKUR000504KA1 Catalog Number :

Device Description : LIGHT

Device Class : 2

Duns Number: 697119498

Premarket Exempt : No

Product Code : EMA, KLE, EBF

Prescription Use : Yes

Device Count : 1

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