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) (5) AGENT, TOOTH BONDING, RESIN (KLE) (2)

Premarket Exempt

No Yes

Clear

Aeliteflo - 00810111540223 Catalog Number : H-671A35F

Device Description : AELITEFLO Composite A3.5 Syr. Pkg

Device Class : 1

Duns Number: 053529939

Premarket Exempt : No

Product Code : EID, EBF

Prescription Use : Yes

Device Count : 1

Aeliteflo - 00810111540254 Catalog Number : H-672B1

Device Description : AELITEFLO L/C Comp B1 1.5gm

Device Class : 2

Duns Number: 053529939

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Aeliteflo - 00810111540261 Catalog Number : H-672B1F

Device Description : AELITEFLO Composite B1 Syr.

Device Class : 1

Duns Number: 053529939

Premarket Exempt : No

Product Code : EID, EBF

Prescription Use : Yes

Device Count : 1

Aeliteflo - 00810111540278 Catalog Number : H-673C2

Device Description : AELITEFLO L/C Comp C2 1.5gm

Device Class : 2

Duns Number: 053529939

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Aeliteflo - 00810111540285 Catalog Number : H-673C2F

Device Description : AELITEFLO Composite C2 Syr. Pkg

Device Class : 1

Duns Number: 053529939

Premarket Exempt : No

Product Code : EID, EBF

Prescription Use : Yes

Device Count : 1

Aeliteflo - 00810111540346 Catalog Number : H-675OWF

Device Description : AELITEFLO Composite White Opaque. Syr. Package

Device Class : 1

Duns Number: 053529939

Premarket Exempt : No

Product Code : EBF, EID

Prescription Use : Yes

Device Count : 1

Aeliteflo - 00810111540353 Catalog Number : H-675TI

Device Description : AELITEFLO L/C Comp Tr 1.5gm

Device Class : 2

Duns Number: 053529939

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Aeliteflo - 00810111540360 Catalog Number : H-675TIF

Device Description : AELITEFLO Composite Tran. Syr.

Device Class : 1

Duns Number: 053529939

Premarket Exempt : No

Product Code : EID, EBF

Prescription Use : Yes

Device Count : 1

All-Bond 3 - 00810111540377 Catalog Number : B-3601

Device Description : All-Bond 3 Part A 6ml Bottle

Device Class : 2

Duns Number: 053529939

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

All-Bond 3 - 00810111540384 Catalog Number : B-3602

Device Description : All-Bond 3 Part B 6ml Bottle

Device Class : 2

Duns Number: 053529939

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

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