Coltène/Whaledent AG

Address:FELDWIESENSTRASSE 20,ALTSTAETTEN Sankt Gallen,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

Material, Impression (ELW) (10)

Premarket Exempt

No Yes

Clear

AFFINIS - 07640181479313 Catalog Number : 6685

Device Class : 2

Duns Number: 480017482

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 20

AFFINIS PRECIOUS - 07640181479368 Catalog Number : 6775

Device Class :

Duns Number: 480017482

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 2

AFFINIS PRECIOUS - 07640181479375 Catalog Number : 6776

Device Class :

Duns Number: 480017482

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 2

AFFINIS BLACK - 07640181479481 Catalog Number : 60019554

Device Class : 2

Duns Number: 480017482

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 2

AFFINIS BLACK - 07640181479528 Catalog Number : 60019776

Device Class : 2

Duns Number: 480017482

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 2

PRESIDENT The Original - 07640181479580 Catalog Number : 60019937

Device Description : PRESIDENT The Original xtra light body 2 x 50ml

Device Class :

Duns Number: 480017482

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 2

PRESIDENT The Original - 07640181479597 Catalog Number : 60019938

Device Description : PRESIDENT The Original light body 2 x 50 ml

Device Class : 2

Duns Number: 480017482

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 2

PRESIDENT The Original - 07640181479603 Catalog Number : 60019939

Device Description : PRESIDENT The Original regular body 2 x 50ml

Device Class : 2

Duns Number: 480017482

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 2

PRESIDENT The Original - 07640181479627 Catalog Number : 60019941

Device Description : PRESIDENT The Original heavy body 2 x 75ml

Device Class : 2

Duns Number: 480017482

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 2

PRESIDENT The Original - 07640181479634 Catalog Number : 60019942

Device Description : PRESIDENT The Original putty 2 x 300 ml

Device Class : 2

Duns Number: 480017482

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

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