BISCO INC.

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

LINER, CAVITY, CALCIUM HYDROXIDE (EJK) (4) AGENT, TOOTH BONDING, RESIN (KLE) (3) SEALANT, PIT AND FISSURE, AND CONDITIONER (EBC) (3) SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL (EID) (2)

Premarket Exempt

No Yes

Clear

TheraCal LC - 00810111540001 Catalog Number : H-3301

Device Description : TheraCal LC 1g Syringe

Device Class : 2

Duns Number: 053529939

Premarket Exempt : No

Product Code : EJK

Prescription Use : Yes

Device Count : 1

TheraCal LC - 00810111540025 Catalog Number : H-33014P

Device Description : TheraCal LC 4 - 1g Syringe Pkg

Device Class : 1

Duns Number: 053529939

Premarket Exempt : No

Product Code : EJK, EID

Prescription Use : Yes

Device Count : 1

TheraCal LC - 00810111540032 Catalog Number : H-3302S

Device Description : TheraCal LC 0.25g Single Syringe SMPL

Device Class : 2

Duns Number: 053529939

Premarket Exempt : No

Product Code : EJK

Prescription Use : Yes

Device Count : 1

TheraCal LC - 00810111540049 Catalog Number : H-3302PS

Device Description : TheraCal LC .25g Syringe Pkg

Device Class : 1

Duns Number: 053529939

Premarket Exempt : No

Product Code : EID, EJK

Prescription Use : Yes

Device Count : 1

Z-Prime Plus - 00810111540056 Catalog Number : B-6001

Device Description : Z-Prime Plus 4ml Single BTL

Device Class : 2

Duns Number: 053529939

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

Z-Prime Plus - 00810111540063 Catalog Number : B-6002

Device Description : Z-Prime Plus 2ml Single BTL

Device Class : 2

Duns Number: 053529939

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

Z-Prime Plus - 00810111540070 Catalog Number : B-6003S

Device Description : Z-Prime Plus 0.5ml BTL SMPL

Device Class : 2

Duns Number: 053529939

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

Bis-Silane - 00810111540087 Catalog Number : B-3211

Device Description : Bis-Silane Primer Part A 6ml

Device Class : 2

Duns Number: 053529939

Premarket Exempt : No

Product Code : EBC

Prescription Use : Yes

Device Count : 1

Bis-Silane - 00810111540094 Catalog Number : B-3212

Device Description : Bis-Silane Primer Part B 6ml

Device Class : 2

Duns Number: 053529939

Premarket Exempt : No

Product Code : EBC

Prescription Use : Yes

Device Count : 1

Bis-Silane - 00810111540100 Catalog Number : B-3210P

Device Description : BIS-SILANE 2-Part Primer Pkg

Device Class : 2

Duns Number: 053529939

Premarket Exempt : No

Product Code : EBC

Prescription Use : Yes

Device Count : 1

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