Candulor AG

Address:Boulevard Lilienthal 8,Glattpark Zurich,CH

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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

RESIN, DENTURE, RELINING, REPAIRING, REBASING (EBI) (8) Denture, plastic, teeth (ELM) (2)

Premarket Exempt

No Yes

Clear

BonSelect TCR - E1996986601 Catalog Number : 698660

Device Description : BonSelect TCR 8er U 08- D3

Device Class : 2

Duns Number: 480467422

Premarket Exempt : Yes

Product Code : ELM

Prescription Use : Yes

Device Count : 1

BonSelect TCR - E1996986611 Catalog Number : 698661

Device Description : BonSelect TCR 8er U 08- D4

Device Class : 2

Duns Number: 480467422

Premarket Exempt : Yes

Product Code : ELM

Prescription Use : Yes

Device Count : 1

XPLEX - E1997095431 Catalog Number : 709543

Device Description : X PLEX 150ML MONOMER COLD

Device Class : 2

Duns Number: 480467422

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

XPLEX - E1997095441 Catalog Number : 709544

Device Description : X PLEX 500ML MONOMER COLD

Device Class : 2

Duns Number: 480467422

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

XPLEX - E1997106571 Catalog Number : 710657

Device Description : X PLEX 150ML MONOMER HOT

Device Class : 2

Duns Number: 480467422

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

XPLEX - E1997106581 Catalog Number : 710658

Device Description : X PLEX 500ML MONOMER HOT

Device Class : 2

Duns Number: 480467422

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

XPLEX - E1997108481 Catalog Number : 710848

Device Description : X PLEX 100G F34

Device Class : 2

Duns Number: 480467422

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

XPLEX - E1997108491 Catalog Number : 710849

Device Description : X PLEX 100G F53

Device Class : 2

Duns Number: 480467422

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

XPLEX - E1997108501 Catalog Number : 710850

Device Description : X PLEX 100G F55

Device Class : 2

Duns Number: 480467422

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

XPLEX - E1997108511 Catalog Number : 710851

Device Description : X PLEX 100G F57

Device Class : 2

Duns Number: 480467422

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

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