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

Point, Paper, Endodontic (EKN) (10)

Premarket Exempt

No Yes

Clear

HYGENIC® Paper Points - E165H032042 Catalog Number : H03204

Device Description : HYGENIC® STER-I-CELL Paper Points conv. # M

Device Class : 1

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : EKN

Prescription Use : Yes

Device Count : 180

HYGENIC® Paper Points - E165H032052 Catalog Number : H03205

Device Description : HYGENIC® STER-I-CELL Paper Points conv. # C

Device Class : 1

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : EKN

Prescription Use : Yes

Device Count : 180

HYGENIC® Paper Points - E165H032062 Catalog Number : H03206

Device Description : HYGENIC® STER-I-CELL Paper Points conv. # XC

Device Class : 1

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : EKN

Prescription Use : Yes

Device Count : 180

HYGENIC® Paper Points - E165H032070 Catalog Number : H03207

Device Description : HYGENIC® STER-I-CELL Paper Points conv. # XXF - XC

Device Class : 1

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : EKN

Prescription Use : Yes

Device Count : 1

HYGENIC® Paper Points - E165H033451 Catalog Number : H03345

Device Description : HYGENIC® Absorbent Paper Points conv. # XXF

Device Class : 1

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : EKN

Prescription Use : Yes

Device Count : 200

HYGENIC® Paper Points - E165H033461 Catalog Number : H03346

Device Description : HYGENIC® Absorbent Paper Points conv. # XF

Device Class : 1

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : EKN

Prescription Use : Yes

Device Count : 200

HYGENIC® Paper Points - E165H033471 Catalog Number : H03347

Device Description : HYGENIC® Absorbent Paper Points conv. # F

Device Class : 1

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : EKN

Prescription Use : Yes

Device Count : 200

HYGENIC® Paper Points - E165H033481 Catalog Number : H03348

Device Description : HYGENIC® Absorbent Paper Points conv. # M

Device Class : 1

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : EKN

Prescription Use : Yes

Device Count : 200

HYGENIC® Paper Points - E165H033491 Catalog Number : H03349

Device Description : HYGENIC® Absorbent Paper Points conv. # C

Device Class : 1

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : EKN

Prescription Use : Yes

Device Count : 200

HYGENIC® Paper Points - E165H033501 Catalog Number : H03350

Device Description : HYGENIC® Absorbent Paper Points conv. # XC

Device Class : 1

Duns Number: 315494443

Premarket Exempt : Yes

Product Code : EKN

Prescription Use : Yes

Device Count : 200

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