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 - 00816594020191 Catalog Number : 90555

Device Description : ACCOLADE,B2,5GM

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

ACCOLADE - 00816594020207 Catalog Number : 90556

Device Description : ACCOLADE,C2,5GM

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

ACCOLADE - 00816594020214 Catalog Number : 90557

Device Description : ACCOLADE,C4,5GM

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

ACCOLADE - 00816594020221 Catalog Number : 90558

Device Description : ACCOLADE,DENTIN,5GM

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

ACCOLADE - 00816594020238 Catalog Number : 90551

Device Description : ACCOLADE,INCISAL,5GM

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

ACCOLADE OP - 00816594020245 Catalog Number : 93597

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

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

ACCOLADE PV - 00816594020252 Catalog Number : 91231

Device Description : ACCOLADE,PV,BROWN,3GM

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

ACCOLADE PV - 00816594020269 Catalog Number : 90559

Device Description : ACCOLADE,PV,EXTRA,LIGHT,3GM

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

ACCOLADE PV - 00816594020276 Catalog Number : 90561

Device Description : ACCOLADE,PV,LIGHT,3GM

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

ACCOLADE PV - 00816594020283 Catalog Number : 91216

Device Description : ACCOLADE,PV,TRY-IN KIT

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

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