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 - 14260538370133 Catalog Number : H01225

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

Device Class : 1

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

HYGENIC® Guttapercha Points - 14260538370140 Catalog Number : H01226

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

Device Class : 1

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

HYGENIC® Guttapercha Points - 14260538370164 Catalog Number : H01304

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

Device Class : 1

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

HYGENIC® Guttapercha Points - 14260538370171 Catalog Number : H01305

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

Device Class : 1

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

HYGENIC® Guttapercha Points - 14260538370188 Catalog Number : H01306

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

Device Class : 1

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

HYGENIC® Guttapercha Points - 14260538370195 Catalog Number : H01469

Device Description : HYGENIC® Guttapercha Points Top color ISO 15

Device Class : 1

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

HYGENIC® Guttapercha Points - 14260538370201 Catalog Number : H01470

Device Description : HYGENIC® Guttapercha Points Top color ISO 20

Device Class : 1

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

HYGENIC® Guttapercha Points - 14260538370218 Catalog Number : H01471

Device Description : HYGENIC® Guttapercha Points Top color ISO 25

Device Class : 1

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

HYGENIC® Guttapercha Points - 14260538370225 Catalog Number : H01472

Device Description : HYGENIC® Guttapercha Points Top color ISO 30

Device Class : 1

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

HYGENIC® Guttapercha Points - 14260538370232 Catalog Number : H01473

Device Description : HYGENIC® Guttapercha Points Top color ISO 35

Device Class : 1

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

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