Heraeus Kulzer GmbH

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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

Denture, plastic, teeth (ELM) (10)

Premarket Exempt

No Yes

Clear

Basic 6, C2 / A10, CE - J014567390110 Catalog Number : 56739011

Device Description : Preformed plastic denture tooth

Device Class : 2

Duns Number: 315666321

Premarket Exempt : No

Product Code : ELM

Prescription Use : Yes

Device Count : 1

Basic 6, C3 / A10, CE - J014567390120 Catalog Number : 56739012

Device Description : Preformed plastic denture tooth

Device Class : 2

Duns Number: 315666321

Premarket Exempt : No

Product Code : ELM

Prescription Use : Yes

Device Count : 1

Basic 6, C4 / A10, CE - J014567390130 Catalog Number : 56739013

Device Description : Preformed plastic denture tooth

Device Class : 2

Duns Number: 315666321

Premarket Exempt : No

Product Code : ELM

Prescription Use : Yes

Device Count : 1

Basic 6, D2 / A10, CE - J014567390140 Catalog Number : 56739014

Device Description : Preformed plastic denture tooth

Device Class : 2

Duns Number: 315666321

Premarket Exempt : No

Product Code : ELM

Prescription Use : Yes

Device Count : 1

Basic 6, D3 / A10, CE - J014567390150 Catalog Number : 56739015

Device Description : Preformed plastic denture tooth

Device Class : 2

Duns Number: 315666321

Premarket Exempt : No

Product Code : ELM

Prescription Use : Yes

Device Count : 1

Basic 6, D4 / A10, CE - J014567390160 Catalog Number : 56739016

Device Description : Preformed plastic denture tooth

Device Class : 2

Duns Number: 315666321

Premarket Exempt : No

Product Code : ELM

Prescription Use : Yes

Device Count : 1

Basic 6, A1 / A11, CE - J014567390170 Catalog Number : 56739017

Device Description : Preformed plastic denture tooth

Device Class : 2

Duns Number: 315666321

Premarket Exempt : No

Product Code : ELM

Prescription Use : Yes

Device Count : 1

Basic 6, A2 / A11, CE - J014567390180 Catalog Number : 56739018

Device Description : Preformed plastic denture tooth

Device Class : 2

Duns Number: 315666321

Premarket Exempt : No

Product Code : ELM

Prescription Use : Yes

Device Count : 1

Basic 6, A3 / A11, CE - J014567390190 Catalog Number : 56739019

Device Description : Preformed plastic denture tooth

Device Class : 2

Duns Number: 315666321

Premarket Exempt : No

Product Code : ELM

Prescription Use : Yes

Device Count : 1

Basic 6, A3.5 / A11, CE - J014567390200 Catalog Number : 56739020

Device Description : Preformed plastic denture tooth

Device Class : 2

Duns Number: 315666321

Premarket Exempt : No

Product Code : ELM

Prescription Use : Yes

Device Count : 1

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