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

CROWN AND BRIDGE, TEMPORARY, RESIN (EBG) (6) MATERIAL, IMPRESSION (ELW) (3) AGENT, TOOTH BONDING, RESIN (KLE) (1)

Premarket Exempt

No Yes

Clear

PONTIC - 00816594023369 Catalog Number : 90138

Device Description : A-LINK,ADHESIVE,5ML

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

PONTIC - 00816594023376 Catalog Number : 90669

Device Description : CART,VPS,PONTIC,A0.5,3059

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

PONTIC - 00816594023383 Catalog Number : 90133

Device Description : CART,PONTIC,A1,25ML

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

SKY SELECT - 00816594023390 Catalog Number : KY9030

Device Description : CART,SKY,C&B,10:1,A1

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

SKY SELECT - 00816594023406 Catalog Number : KY9031

Device Description : CART,SKY,C&B.10:1,A2

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

SKY SELECT - 00816594023413 Catalog Number : KY9032

Device Description : CART,SKY,C&B,10:1,A3

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

SKY SELECT - 00816594023420 Catalog Number : KY9033

Device Description : CART,SKY,C&B,10:1,A3.5

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

SKY SELECT - 00816594023437 Catalog Number : KY9034

Device Description : CART,SKY,C&B,10:1,B1

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

SKY SELECT - 00816594023444 Catalog Number : KY9035

Device Description : CART,SKY,C&B,10:1,BLEACH

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

SKY SELECT - 00816594023451 Catalog Number : KY9021

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

Device Class : 2

Duns Number: 601302743

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

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