DANVILLE MATERIALS, LLC

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

ACCOLADE OP - 00816594020092 Catalog Number : 93598

Device Description : ACCOLADE,OP,WHITE,2GM,FA

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

ACCOLADE - 00816594020108 Catalog Number : 90552

Device Description : ACCOLADE,A0,5GM

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

ACCOLADE - 00816594020115 Catalog Number : 90553

Device Description : ACCOLADE,A00op,5GM

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

ACCOLADE - 00816594020122 Catalog Number : 90546

Device Description : ACCOLADE,A1,5GM

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

ACCOLADE - 00816594020139 Catalog Number : 90547

Device Description : ACCOLADE,A2,5GM

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

ACCOLADE - 00816594020146 Catalog Number : 90548

Device Description : ACCOLADE,A3,5GM FA

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

ACCOLADE - 00816594020153 Catalog Number : 90549

Device Description : ACCOLADE,A3.5,5GM

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

ACCOLADE - 00816594020160 Catalog Number : 90840

Device Description : ACCOLADE,A4,5GM

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

ACCOLADE - 00816594020177 Catalog Number : 90554

Device Description : ACCOLADE,A5,5GM

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

ACCOLADE - 00816594020184 Catalog Number : 90550

Device Description : ACCOLADE,B1,5GM

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

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