BISCO INC.

Address:1100 WEST IRVING PARK RD.,Schaumburg,IL,60193,US

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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) (8) SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL (EID) (3) SEALANT, PIT AND FISSURE, AND CONDITIONER (EBC) (2)

Premarket Exempt

No Yes

Clear

Porcelain Primer - 00810111540117 Catalog Number : B-2221

Device Description : PORCELAIN PRIMER 10ml

Device Class : 2

Duns Number: 053529939

Premarket Exempt : No

Product Code : EBC

Prescription Use : Yes

Device Count : 1

Porcelain Primer - 00810111540124 Catalog Number : B-2223

Device Description : Porcelain Primer 3ml Btl

Device Class : 2

Duns Number: 053529939

Premarket Exempt : No

Product Code : EBC

Prescription Use : Yes

Device Count : 1

Aeliteflo - 00810111540131 Catalog Number : H-671A1

Device Description : AELITEFLO L/C Comp A1 1.5gm

Device Class : 2

Duns Number: 053529939

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Aeliteflo - 00810111540148 Catalog Number : H-671A1F

Device Description : AELITEFLO Composite A1 Syr.

Device Class : 1

Duns Number: 053529939

Premarket Exempt : No

Product Code : EID, EBF

Prescription Use : Yes

Device Count : 1

Aeliteflo - 00810111540155 Catalog Number : H-671A2

Device Description : AELITEFLO L/C Comp A2 1.5gm

Device Class : 2

Duns Number: 053529939

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Aeliteflo - 00810111540162 Catalog Number : H-671A2F

Device Description : AELITEFLO Composite A2 Syr.

Device Class : 1

Duns Number: 053529939

Premarket Exempt : No

Product Code : EID, EBF

Prescription Use : Yes

Device Count : 1

Aeliteflo - 00810111540179 Catalog Number : H-671A2O

Device Description : AELITEFLO Composite A2O 1.5gm

Device Class : 2

Duns Number: 053529939

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Aeliteflo - 00810111540193 Catalog Number : H-671A3

Device Description : AELITEFLO L/C Comp A3 1.5gm

Device Class : 2

Duns Number: 053529939

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Aeliteflo - 00810111540209 Catalog Number : H-671A3F

Device Description : AELITEFLO Composite A3 Syr.

Device Class : 1

Duns Number: 053529939

Premarket Exempt : No

Product Code : EID, EBF

Prescription Use : Yes

Device Count : 1

Aeliteflo - 00810111540216 Catalog Number : H-671A35

Device Description : AELITEFLO L/C Comp A3.5 1.5gm

Device Class : 2

Duns Number: 053529939

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

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