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

Cement, Dental (EMA) (9) Agent, Tooth Bonding, Resin (KLE) (1) Syringe, Restorative And Impression Material (EID) (1)

Premarket Exempt

No Yes

Clear

ESTECEM II - 04548190161485 Catalog Number :

Device Description : KIT UNIVERSAL

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : KLE, EMA

Prescription Use : Yes

Device Count : 1

ESTECEM II - 04548190161584 Catalog Number :

Device Description : PASTE UNIVERSAL

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

ESTECEM II - 04548190161683 Catalog Number :

Device Description : PASTE CLEAR

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

ESTECEM II - 04548190161782 Catalog Number :

Device Description : PASTE BROWN

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

ESTECEM II - 04548190161881 Catalog Number :

Device Description : PASTE WHITE OPAQUE

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Cement Mixing Tip - 04548190161935 Catalog Number :

Device Description : Mixing tip for cement

Device Class : 1

Duns Number: 693552176

Premarket Exempt : Yes

Product Code : EID

Prescription Use : Yes

Device Count : 40

BIstite II DC - 04548190163069 Catalog Number :

Device Description : Kit Clear

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

BIstite II DC - 04548190163076 Catalog Number :

Device Description : Kit Ivory

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

BIstite II DC - 04548190163083 Catalog Number :

Device Description : Kit Dentin

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

BIstite II DC - 04548190163113 Catalog Number :

Device Description : Paste Clear

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

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