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, A4 / A11, CE - J014567390210 Catalog Number : 56739021

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, B1 / A11, CE - J014567390220 Catalog Number : 56739022

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, B2 / A11, CE - J014567390230 Catalog Number : 56739023

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, B3 / A11, CE - J014567390240 Catalog Number : 56739024

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, B4 / A11, CE - J014567390250 Catalog Number : 56739025

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, C1 / A11, CE - J014567390260 Catalog Number : 56739026

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, C2 / A11, CE - J014567390270 Catalog Number : 56739027

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 / A11, CE - J014567390280 Catalog Number : 56739028

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 / A11, CE - J014567390290 Catalog Number : 56739029

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 / A11, CE - J014567390300 Catalog Number : 56739030

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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