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

Agent, Tooth Bonding, Resin (KLE) (4) Crown And Bridge, Temporary, Resin (EBG) (3) Cement, Dental (EMA) (2) Liner, Cavity, Calcium Hydroxide (EJK) (1)

Premarket Exempt

Clear

Oxford Bond TE Mono - EFSM200010 Catalog Number :

Device Description : Total Etch Adhesive - Light Cure

Device Class : 2

Duns Number: 341553292

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

Oxford Bond SE Mono - EFSM210010 Catalog Number :

Device Description : Light Cure Self Etch Adhesive

Device Class : 2

Duns Number: 341553292

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

Oxford Bond SE Dual - EFSM210020 Catalog Number :

Device Description : Self Etching Adhesive - Dual Cure

Device Class : 2

Duns Number: 341553292

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

Oxford Universal Bond - EFSM210050 Catalog Number :

Device Description : Universal Adhesive

Device Class : 2

Duns Number: 341553292

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

Oxford Cal VLC - EFSM230010 Catalog Number :

Device Description : Light Cure Calcium Hydroxide Liner

Device Class :

Duns Number: 341553292

Premarket Exempt : No

Product Code : EJK

Prescription Use : Yes

Device Count : 2

Oxford Temp A1 - EFSM30001A10 Catalog Number :

Device Description : Temporary Crown & Bridge Material 10:1

Device Class : 2

Duns Number: 341553292

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

Oxford Temp A2 - EFSM30001A20 Catalog Number :

Device Description : Temporary Crown & Bridge Material 10:1

Device Class : 2

Duns Number: 341553292

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

Oxford Temp A3 - EFSM30001A30 Catalog Number :

Device Description : Temporary Crown & Bridge Material 10:1

Device Class : 2

Duns Number: 341553292

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

Oxford Temp CEM Flexi-Trans - EFSM320010 Catalog Number :

Device Description : Dual Cure Translucent Temporary Cement

Device Class : 2

Duns Number: 341553292

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Oxford Temp CEM Universal - EFSM320020 Catalog Number :

Device Description : Non-Eugenol Temporary Cement

Device Class : 2

Duns Number: 341553292

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

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