Coltène/Whaledent GmbH + Co. KG

Address:RAIFFEISENSTRASSE 30,LANGENAU Baden-Wurttemberg,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

Gutta-Percha (EKM) (10)

Premarket Exempt

No Yes

Clear

HYGENIC® Guttapercha Points - 14260538370249 Catalog Number : H01474

Device Description : HYGENIC® Guttapercha Points Top color ISO 40

Device Class : 1

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

HYGENIC® Guttapercha Points - 14260538370256 Catalog Number : H01475

Device Description : HYGENIC® Guttapercha Points Top color ISO 45

Device Class : 1

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

HYGENIC® Guttapercha Points - 14260538370263 Catalog Number : H01476

Device Description : HYGENIC® Guttapercha Points Top color ISO 50

Device Class : 1

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

HYGENIC® Guttapercha Points - 14260538370270 Catalog Number : H01477

Device Description : HYGENIC® Guttapercha Points Top color ISO 55

Device Class : 1

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

HYGENIC® Guttapercha Points - 14260538370287 Catalog Number : H01478

Device Description : HYGENIC® Guttapercha Points Top color ISO 60

Device Class : 1

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

HYGENIC® Guttapercha Points - 14260538370294 Catalog Number : H01479

Device Description : HYGENIC® Guttapercha Points Top color ISO 70

Device Class : 1

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

HYGENIC® Guttapercha Points - 14260538370300 Catalog Number : H01480

Device Description : HYGENIC® Guttapercha Points Top color ISO 80

Device Class : 1

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

HYGENIC® Guttapercha Points - 14260538370317 Catalog Number : H01481

Device Description : HYGENIC® Guttapercha Points Top color ISO 90

Device Class : 1

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

HYGENIC® Guttapercha Points - 14260538370324 Catalog Number : H01482

Device Description : HYGENIC® Guttapercha Points Top color ISO 100

Device Class : 1

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

HYGENIC® Guttapercha Points - 14260538370331 Catalog Number : H01483

Device Description : HYGENIC® Guttapercha Points Top color ISO 110

Device Class : 1

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

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