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) (7) Catheter And Tip, Suction (JOL) (3)

Premarket Exempt

No Yes

Clear

HYGENIC® Guttapercha Points - 04260614072541 Catalog Number : 60026844

Device Description : HYGENIC® Guttapercha Points Top color ISO 15 - 40

Device Class : 1

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 1

HYGENIC® Guttapercha Points - 04260614072558 Catalog Number : 60026845

Device Description : HYGENIC® Guttapercha Points Top color ISO 45 - 80

Device Class : 1

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 1

HYGENIC® Guttapercha Points - 04260614072565 Catalog Number : 60026846

Device Description : HYGENIC® Guttapercha Points Top color ISO 90 - 140

Device Class : 1

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 1

ROEKO Surgitip-micro - 04260614073173 Catalog Number : 462013

Device Class : 2

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : JOL

Prescription Use : Yes

Device Count : 1

ROEKO Surgitip - 04260614073180 Catalog Number : 462026

Device Class : 2

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : JOL

Prescription Use : Yes

Device Count : 1

ROEKO Surgitip - 04260614073197 Catalog Number : 462049

Device Class : 2

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : JOL

Prescription Use : Yes

Device Count : 1

HYGENIC® Guttapercha Points - 14260538370096 Catalog Number : H01221

Device Description : HYGENIC® Guttapercha Points pink conv. # XF

Device Class : 1

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

HYGENIC® Guttapercha Points - 14260538370102 Catalog Number : H01222

Device Description : HYGENIC® Guttapercha Points pink conv. # FF

Device Class : 1

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

HYGENIC® Guttapercha Points - 14260538370119 Catalog Number : H01223

Device Description : HYGENIC® Guttapercha Points pink conv. # MF

Device Class : 1

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

HYGENIC® Guttapercha Points - 14260538370126 Catalog Number : H01224

Device Description : HYGENIC® Guttapercha Points pink conv. # F

Device Class : 1

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

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