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, Tooth Shade, Resin (EBF) (4) Agent, Tooth Bonding, Resin (KLE) (2)

Premarket Exempt

No Yes

Clear

Micro Esthetic 20 Compules B2 - EBIB751041 Catalog Number : 75104

Device Description : Light curing microhybrit composite

Device Class : 2

Duns Number: 316133664

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

BISICO Repo-Core DC A3 Mini - EBIB752001 Catalog Number : 75200

Device Description : Double-curing, free-flowing, radiopaque composite material that is used to build Double-curing, free-flowing, radiopaque composite material that is used to build the core and cement roots. Used by a dentist.

Device Class : 2

Duns Number: 316133664

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

BISICO Repo-Core DC A3 25ml - EBIB752201 Catalog Number : 75220

Device Class : 2

Duns Number: 316133664

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

BISICO Cem DC A3 - EBIB752401 Catalog Number : 75240

Device Description : Double-curing, fine-flowing micro-hybrid composite material for permanent attach Double-curing, fine-flowing micro-hybrid composite material for permanent attachment of crowns, bridges, inlays and endodontic posts made of carbon fibers and glass fibers. Used by a dentist.

Device Class : 2

Duns Number: 316133664

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

E-Bond DC - EBIB752501 Catalog Number : 75250

Device Description : Self-etching and dual-curing bonding system. Bonding of composite, compomer or r Self-etching and dual-curing bonding system. Bonding of composite, compomer or resin-modified glass ionomer cements with enamel and dentin. Used in dentistry

Device Class : 2

Duns Number: 316133664

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

E-Bond LC - EBIB752651 Catalog Number : 75265

Device Description : Self-etching and light-curing bonding system. Bonding of light-curing composite Self-etching and light-curing bonding system. Bonding of light-curing composite to enamel and dentin. Used in dentistry.

Device Class : 2

Duns Number: 316133664

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

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