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) (10)

Premarket Exempt

No Yes

Clear

Estelite Color - 04548190109180 Catalog Number :

Device Description : Red

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Estelite Color - 04548190109197 Catalog Number :

Device Description : Lavender

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Estelite Color - 04548190109203 Catalog Number :

Device Description : Pink Opaque

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Estelite Color - 04548190109210 Catalog Number :

Device Description : High Chroma Opaque

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Estelite Color - 04548190109227 Catalog Number :

Device Description : Medium Chroma Opaque

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Estelite Color - 04548190109234 Catalog Number :

Device Description : Low Chroma Opaque

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Estelite Flow Quick - 04548190120215 Catalog Number :

Device Description : PLT A1

Device Class :

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 20

Estelite Flow Quick - 04548190120222 Catalog Number :

Device Description : PLT A2

Device Class :

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 20

Estelite Flow Quick - 04548190120239 Catalog Number :

Device Description : PLT A3

Device Class :

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 20

Estelite Flow Quick - 04548190120246 Catalog Number :

Device Description : PLT A3.5

Device Class :

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 20

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