bisico Bielefelder Dentalsilicone GmbH & Co. KG

Address:Johanneswerkstrasse 3,BIELEFELD North Rhine-Westphalia,DE

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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) (6) Material, Impression Tray, Resin (EBH) (4)

Premarket Exempt

No Yes

Clear

BISICO Lutesil 96 - EBIB002901 Catalog Number : 00290

Device Description : condensation-curing dental impression silicone

Device Class : 1

Duns Number: 316133664

Premarket Exempt : Yes

Product Code : EBH

Prescription Use : Yes

Device Count : 1

BISICO Exact N - EBIB003101 Catalog Number : 00310

Device Description : condensation-curing dental impression silicone

Device Class : 1

Duns Number: 316133664

Premarket Exempt : No

Product Code : EBH

Prescription Use : Yes

Device Count : 1

BISICO Regidur blue - EBIB005301 Catalog Number : 00530

Device Description : condensation-curing dental impression silicone

Device Class : 2

Duns Number: 316133664

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

BISICO Liquid Hardener A - EBIB008101 Catalog Number : 00810

Device Description : Liquid hardener (catalyst) for mixing with condensation-curing impression silico Liquid hardener (catalyst) for mixing with condensation-curing impression silicones (C-silicones). The product is used in dentistry and in the laboratory.

Device Class : 1

Duns Number: 316133664

Premarket Exempt : Yes

Product Code : EBH

Prescription Use : Yes

Device Count : 1

BISICO Paste Hardener - EBIB009501 Catalog Number : 00950

Device Description : Hardening paste (catalyst) for mixing with condensation-curing impression silico Hardening paste (catalyst) for mixing with condensation-curing impression silicones (C-silicones). The product is used in dentistry and in the laboratory.

Device Class : 1

Duns Number: 316133664

Premarket Exempt : Yes

Product Code : EBH

Prescription Use : Yes

Device Count : 1

BISICO S1 soft - EBIB010601 Catalog Number : 01060

Device Description : Addition-curing dental impression silicone

Device Class : 2

Duns Number: 316133664

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

BISICO S1 suhy - EBIB010901 Catalog Number : 01090

Device Description : Addition-curing dental impression silicone

Device Class : 2

Duns Number: 316133664

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

BISICO S1 - EBIB011201 Catalog Number : 01120

Device Description : Addition-curing dental impression silicone

Device Class : 2

Duns Number: 316133664

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

BISICO Mandisil - EBIB012201 Catalog Number : 01220

Device Description : Addition-curing dental impression silicone

Device Class : 2

Duns Number: 316133664

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

BISICO Function - EBIB013501 Catalog Number : 01350

Device Description : Addition-curing dental impression silicone

Device Class : 2

Duns Number: 316133664

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

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