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 - 04548190107223 Catalog Number :

Device Description : Syringe EA2

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Estelite Omega - 04548190107230 Catalog Number :

Device Description : Syringe EA3

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Estelite Omega - 04548190107247 Catalog Number :

Device Description : Syringe EB1

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Estelite Omega - 04548190107254 Catalog Number :

Device Description : Syringe Trans

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Estelite Omega - 04548190107261 Catalog Number :

Device Description : Syringe MW

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Estelite Omega - 04548190107278 Catalog Number :

Device Description : Syringe DA1

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Estelite Omega - 04548190107285 Catalog Number :

Device Description : Syringe DA2

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Estelite Omega - 04548190107292 Catalog Number :

Device Description : Syringe DA3

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Estelite Omega - 04548190107308 Catalog Number :

Device Description : Syringe BL1

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Estelite Omega - 04548190107315 Catalog Number :

Device Description : Syringe BL2

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

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