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

Syringe, Restorative And Impression Material (EID) (5) Resin, Denture, Relining, Repairing, Rebasing (EBI) (4)

Premarket Exempt

No Yes

Clear

Sofreliner Tough - 04548190233564 Catalog Number :

Device Description : M Paste

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

TOKUYAMA DISPENSER II - 04548190233724 Catalog Number :

Device Description : Dispensor for Sofreliner

Device Class : 1

Duns Number: 693552176

Premarket Exempt : Yes

Product Code : EID

Prescription Use : Yes

Device Count : 1

TD II MIXING TIP - 04548190233809 Catalog Number :

Device Description : XS

Device Class : 1

Duns Number: 693552176

Premarket Exempt : Yes

Product Code : EID

Prescription Use : Yes

Device Count : 50

TD II MIXING TIP - 04548190233816 Catalog Number :

Device Description : S

Device Class : 1

Duns Number: 693552176

Premarket Exempt : Yes

Product Code : EID

Prescription Use : Yes

Device Count : 50

Sofreliner Tough - 04548190234011 Catalog Number :

Device Description : S Kit

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Sofreliner Tough - 04548190234110 Catalog Number :

Device Description : S Paste

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Sofreliner Tough - 04548190234417 Catalog Number :

Device Description : Primer

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

NOZZLE FOR MINI MIXING TIP - 04548190346554 Catalog Number :

Device Description : Nozzle for MINI MIXING TIP S

Device Class : 1

Duns Number: 693552176

Premarket Exempt : Yes

Product Code : EID

Prescription Use : Yes

Device Count : 40

MINI MIXING TIP - 04548190346608 Catalog Number :

Device Description : Mini mixing tip S for cement

Device Class : 1

Duns Number: 693552176

Premarket Exempt : Yes

Product Code : EID

Prescription Use : Yes

Device Count : 40

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