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, IMPRESSION (ELW) (7) CROWN AND BRIDGE, TEMPORARY, RESIN (EBG) (3)

Premarket Exempt

No Yes

Clear

SKY SELECT - 00816594023468 Catalog Number : KY9028

Device Description : CART,SKY,FS,LIGHT,BODY

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

SKY SELECT - 00816594023475 Catalog Number : KY9029

Device Description : CART,SKY,FS,MED.BODY

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

SKY SELECT - 00816594023482 Catalog Number : KY9020

Device Description : CART,SKY,FS,MONOPHASE

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

SKY SELECT - 00816594023499 Catalog Number : KY9024

Device Description : CART,SKY,RS,MED.BODY

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

SKY SELECT - 00816594023505 Catalog Number : KY9023

Device Description : CART,SKY,RS LIGHT,BODY

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

SKY SELECT - 00816594023512 Catalog Number : KY9025

Device Description : CART,SKY,RS MONOPHASE

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

SKY SELECT - 00816594023529 Catalog Number : KY9027

Device Description : CART,SKY,RS,HEAVY,BODY

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

SDI - 00816594023598 Catalog Number : 410-5001

Device Description : SUPPLY DOC,C&B,4:1,A-1

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

SDI - 00816594023604 Catalog Number : 410-5002

Device Description : SUPPLY DOC,C&B,4:1,A-2

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

SDI - 00816594023611 Catalog Number : 410-5003

Device Description : SUPPLY DOC,C&B,4:1,A-3

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

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