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) (8) Agent, Tooth Bonding, Resin (KLE) (1) Resin, Denture, Relining, Repairing, Rebasing (EBI) (1)

Premarket Exempt

No Yes

Clear

BIstite II DC - 04548190163120 Catalog Number :

Device Description : Paste Ivory

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

BIstite II DC - 04548190163137 Catalog Number :

Device Description : Paste Dentin

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

BIstite II DC - 04548190163366 Catalog Number :

Device Description : Primer 1A

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

BIstite II DC - 04548190163373 Catalog Number :

Device Description : Primer 1B

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

BIstite II DC - 04548190163380 Catalog Number :

Device Description : Primer 2

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Bistite II DC - 04548190163717 Catalog Number :

Device Description : Air Barrier

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Tokuso Ceramic Primer - 04548190165438 Catalog Number :

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Metaltite - 04548190165476 Catalog Number :

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Tokuso Rebase MR Bond - 04548190201334 Catalog Number :

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

Tokuso Resin Hardner II - 04548190201716 Catalog Number :

Device Class : 2

Duns Number: 693552176

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

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