Vista Dental

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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) (6) Agent, Tooth Bonding, Resin (KLE) (4)

Premarket Exempt

No Yes

Clear

Titan Flowable Composite - 6 Syringes of A2 Shade - 00818207020680 Catalog Number :

Device Class : 2

Duns Number: 036623932

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Titan Flowable Composite- 4 Syringes of A3.5 Shade - 00818207020697 Catalog Number :

Device Class : 2

Duns Number: 036623932

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Titan Flowable Composite- 4 Syringes of B1 Shade - 00818207020703 Catalog Number :

Device Class : 2

Duns Number: 036623932

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Self-Etch Refill - 00818207020710 Catalog Number :

Device Class : 2

Duns Number: 036623932

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

Self-Etch Bottle 1 - 00818207020727 Catalog Number :

Device Class : 2

Duns Number: 036623932

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

Self-Etch Bottle 2 - 00818207020734 Catalog Number :

Device Class : 2

Duns Number: 036623932

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

Self-etch Bottle 3 - 00818207020741 Catalog Number :

Device Class : 2

Duns Number: 036623932

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

A Shade Variety Pack (A1, A2, A2, A3, A3.5, A4) REGEN Flowable Composite 6 syrin - 00818207020758 Catalog Number :

Device Class : 2

Duns Number: 036623932

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Variety Pack (A1, A2, A4, B1, TR, WO) REGEN Flowable Composite 6 Syringe - 00818207020765 Catalog Number :

Device Class : 2

Duns Number: 036623932

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

A3 REGEN Flowable Composite 4pk of Syringes - 00818207020772 Catalog Number :

Device Class : 2

Duns Number: 036623932

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

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