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 Omega - 04548190107414 Catalog Number :

Device Description : PLT EA1

Device Class :

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 20

Estelite Omega - 04548190107421 Catalog Number :

Device Description : PLT EA2

Device Class :

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 20

Estelite Omega - 04548190107438 Catalog Number :

Device Description : PLT EA3

Device Class :

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 20

Estelite Omega - 04548190107445 Catalog Number :

Device Description : PLT EB1

Device Class :

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 20

Estelite Omega - 04548190107452 Catalog Number :

Device Description : PLT Trans

Device Class :

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 20

Estelite Omega - 04548190107469 Catalog Number :

Device Description : PLT MW

Device Class :

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 20

Estelite Omega - 04548190107476 Catalog Number :

Device Description : PLT DA1

Device Class :

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 20

Estelite Omega - 04548190107483 Catalog Number :

Device Description : PLT DA2

Device Class :

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 20

Estelite Omega - 04548190107490 Catalog Number :

Device Description : PLT DA3

Device Class :

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 20

Estelite Omega - 04548190107506 Catalog Number :

Device Description : PLT BL1

Device Class :

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 20

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