TOKUYAMA DENTAL CORPORATION

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

OMNICHROMA - 04548190101160 Catalog Number :

Device Description : SYRINGE

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

OMNICHROMA BLOCKER - 04548190101177 Catalog Number :

Device Description : SYRINGE

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

OMNICHROMA - 04548190101269 Catalog Number :

Device Description : PLT

Device Class :

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 20

OMNICHROMA BLOCKER - 04548190101276 Catalog Number :

Device Description : PLT

Device Class :

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 20

OMNICHROMA - 04548190101306 Catalog Number :

Device Description : PLT Sample

Device Class :

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 20

OMNICHROMA BLOCKER - 04548190101313 Catalog Number :

Device Description : PLT Sample

Device Class :

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 10

OMNICHROMA - 04548190101320 Catalog Number :

Device Description : Syringe Sample

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

OMNICHROMA BLOCKER - 04548190101337 Catalog Number :

Device Description : Syringe Sample

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

OMNICHROMA - 04548190101412 Catalog Number :

Device Description : SYRINGE SAMPLE KIT

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

OMNICHROMA - 04548190101511 Catalog Number :

Device Description : PLT SAMPLE KIT

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

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