DANVILLE MATERIALS, LLC

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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

ARIA - 00816594020498 Catalog Number : 89361

Device Description : ARIA,A2,RFL,5GM

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

ARIA - 00816594020504 Catalog Number : 89358

Device Description : ARIA,A3.5,1GM

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

ARIA - 00816594020511 Catalog Number : 89362

Device Description : ARIA,A3.5,RFL,5GM

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

ARIA - 00816594020528 Catalog Number : 89359

Device Description : ARIA,INCISAL,RFL,1GM

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

ARIA - 00816594020535 Catalog Number : 89363

Device Description : ARIA,INCISAL,RFL,5GM

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

ARIA - 00816594020542 Catalog Number : 89355

Device Description : ARIA,INTRO KIT 4 X 1GM

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

STARTFLOW - 00816594020559 Catalog Number : 85071

Device Description : STARTFLOW,5GM,INTRO

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

STARTFLOW - 00816594020566 Catalog Number : 89466

Device Description : STARTFLOW,A0,1GM,REFILL

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

STARTFLOW - 00816594020573 Catalog Number : 89397

Device Description : STARTFLOW,A0,5GM,REFILL

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

STARTFLOW - 00816594020580 Catalog Number : 89465

Device Description : STARTFLOW,A00,1GM,OPAQUE

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

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