First Scientific Dental Materials GmbH

Address:Robert-Bosch-Strasse 2,Elmshorn Schleswig-Holstein,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) (8) Cement, Dental (EMA) (1) Resin, Root Canal Filling (KIF) (1)

Premarket Exempt

Clear

Oxford SpheriChrome - EFSM100070 Catalog Number :

Device Description : One Material Thousand Shades - Light Cure Restorative Composite

Device Class : 2

Duns Number: 341553292

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Oxford SpheriBlokk - EFSM100100 Catalog Number :

Device Description : Blocker for Oxford SpheriChrome - Light Cure Restorative Composite

Device Class : 2

Duns Number: 341553292

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Oxford SpheriChrome Flow - EFSM110040 Catalog Number :

Device Description : One Material Thousand Shades - Light Cure Flowable Restorative Composite

Device Class : 2

Duns Number: 341553292

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 2

Oxford Zircore NANO A2 - EFSM12001A20 Catalog Number :

Device Description : Premium Dual cure Core Build-up and Post Cementing Composite

Device Class : 2

Duns Number: 341553292

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Oxford Zircore NANO A3 - EFSM12001A30 Catalog Number :

Device Description : Premium Dual cure Core Build-up and Post Cementing Composite

Device Class : 2

Duns Number: 341553292

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Oxford Zircore NANO Blue - EFSM12001BLUE0 Catalog Number :

Device Description : Premium Dual cure Core Build-up and Post Cementing Composite

Device Class : 2

Duns Number: 341553292

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Oxford Flo CEM A3 - EFSM12005A30 Catalog Number :

Device Description : Dual Cure Flowable Composite Cement

Device Class : 2

Duns Number: 341553292

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Oxford Cem IMPLANT - EFSM120080 Catalog Number :

Device Description : Semi-Permant Cement for Crowns and Bridges on Implants

Device Class : 2

Duns Number: 341553292

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Oxford Zircore NANO A2 - EFSM12013A20 Catalog Number :

Device Description : Premium Dual cure Core Build-up and Post Cementing Composite

Device Class : 2

Duns Number: 341553292

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 2

Oxford Root FILL System - EFSM150020 Catalog Number :

Device Description : Dual Cure Permanent Root Canal Sealing and Filling Material

Device Class : 2

Duns Number: 341553292

Premarket Exempt : No

Product Code : KIF

Prescription Use : Yes

Device Count : 2

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