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 PV - 00816594020290 Catalog Number : 91237

Device Description : ACCOLADE,PV,TRY-IN,BROWN,3GM

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

ACCOLADE PV - 00816594020306 Catalog Number : 91234

Device Description : ACCOLADE,PV,TRY-IN,LIGHT,3GM

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

ACCOLADE PV - 00816594020313 Catalog Number : 91233

Device Description : ACCOLADE,PV,TRY-IN,TRANSL.5GM

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

ACCOLADE PV - 00816594020320 Catalog Number : 91236

Device Description : ACCOLADE,PV,TRY-IN,WHT,OPQ,3GM

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

ACCOLADE PV - 00816594020337 Catalog Number : 91235

Device Description : ACCOLADE,PV,TRY-IN,XTRA LT,3GM

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

ACCOLADE PV - 00816594020344 Catalog Number : 91238

Device Description : ACCOLADE,PV,TRY-IN,YELLOW,3GM

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

ACCOLADE PV - 00816594020351 Catalog Number : 90562

Device Description : ACCOLADE,PV,WHITE,OPAQUER,3GM

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

ACCOLADE PV - 00816594020368 Catalog Number : 90560

Device Description : ACCOLADE,PV,XLUCENT,5GM

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

ACCOLADE PV - 00816594020375 Catalog Number : 91232

Device Description : ACCOLADE,PV,YELLOW,3GM

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

ACCOLADE SRO - 00816594020382 Catalog Number : 91387

Device Description : ACCOLADE,SRO,A2,5GM

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

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