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 FLOW - 04548190102204 Catalog Number :

Device Description : SYRINGE

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

OMNICHROMA FLOW BULK - 04548190102211 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 FLOW - 04548190102228 Catalog Number :

Device Description : SYRINGE

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

OMNICHROMA FLOW - 04548190102242 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 FLOW BULK - 04548190102259 Catalog Number :

Device Description : TRIAL SYRINGE

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Estelite Omega - 04548190107018 Catalog Number :

Device Description : Syringe Deluxe Kit

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Estelite Omega - 04548190107025 Catalog Number :

Device Description : Syringe Basic Kit

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Estelite Omega - 04548190107117 Catalog Number :

Device Description : PLT Deluxe Kit

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Estelite Omega - 04548190107124 Catalog Number :

Device Description : PLT Basic Kit

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Estelite Omega - 04548190107216 Catalog Number :

Device Description : Syringe EA1

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

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