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) (7) MATERIAL, IMPRESSION (ELW) (3)

Premarket Exempt

Yes No

Clear

Artic 8 Living Mould Chart B1 - J014400055110 Catalog Number : 40005511

Device Class : 2

Duns Number: 315666321

Premarket Exempt : No

Product Code : ELM

Prescription Use : Yes

Device Count : 1

Artic 6 living Mould Chart A1 - J014400055120 Catalog Number : 40005512

Device Class : 2

Duns Number: 315666321

Premarket Exempt : No

Product Code : ELM

Prescription Use : Yes

Device Count : 1

Artic 8 Living Mould Chart A1 - J014400055130 Catalog Number : 40005513

Device Class : 2

Duns Number: 315666321

Premarket Exempt : No

Product Code : ELM

Prescription Use : Yes

Device Count : 1

Mondial 6i Returns - J014400058000 Catalog Number : 40005800

Device Description : Denture, plastic, teeth

Device Class : 2

Duns Number: 315666321

Premarket Exempt : No

Product Code : ELM

Prescription Use : Yes

Device Count : 1

Mondial 8i Returns - J014400058010 Catalog Number : 40005801

Device Description : Denture, plastic, teeth

Device Class : 2

Duns Number: 315666321

Premarket Exempt : No

Product Code : ELM

Prescription Use : Yes

Device Count : 1

Mondial/Mondial I Living Mould Chart B1 - J014400058100 Catalog Number : 40005810

Device Class : 2

Duns Number: 315666321

Premarket Exempt : No

Product Code : ELM

Prescription Use : Yes

Device Count : 1

Mondial/Mondial I Living Mould Chart B1 - J014400058110 Catalog Number : 40005811

Device Class : 2

Duns Number: 315666321

Premarket Exempt : No

Product Code : ELM

Prescription Use : Yes

Device Count : 1

FLEXITIME EASY PUTTY 1 X 600 ML - J014500348020 Catalog Number : 50034802

Device Description : Material, Impression

Device Class : 2

Duns Number: 315666321

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

FLEXITIME HEAVY TRAY 1X(2 X 50 ML) - J014500348040 Catalog Number : 50034804

Device Description : Material, Impression

Device Class : 2

Duns Number: 315666321

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

FLEXITIME CORRECT FLOW 1 X (2 X 50 ML) - J014500348060 Catalog Number : 50034806

Device Description : Material, Impression

Device Class : 2

Duns Number: 315666321

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

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