TOKUYAMA DENTAL CORPORATION

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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) (9) Applicator, Resin (KXR) (1)

Premarket Exempt

No Yes

Clear

Estelite Omega - 04548190107513 Catalog Number :

Device Description : PLT BL2

Device Class :

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 20

Brush No.24 - 04548190107629 Catalog Number :

Device Description : Brush for composite

Device Class :

Duns Number: 693552176

Premarket Exempt : Yes

Product Code : KXR

Prescription Use : Yes

Device Count : 5

Estelite Color - 04548190109012 Catalog Number :

Device Description : Kit

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Estelite Color - 04548190109111 Catalog Number :

Device Description : Clear

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Estelite Color - 04548190109128 Catalog Number :

Device Description : White

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Estelite Color - 04548190109135 Catalog Number :

Device Description : Blue

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Estelite Color - 04548190109142 Catalog Number :

Device Description : Yellow

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Estelite Color - 04548190109159 Catalog Number :

Device Description : Gray

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Estelite Color - 04548190109166 Catalog Number :

Device Description : Ochre

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Estelite Color - 04548190109173 Catalog Number :

Device Description : Dark Brown

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

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