Heraeus Kulzer GmbH

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

MATERIAL, IMPRESSION (ELW) (5) Denture, plastic, teeth (ELM) (4) SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL (EID) (1)

Premarket Exempt

No Yes

Clear

Mondial living Mould Chart A1 - J014400034010 Catalog Number : 40003401

Device Class : 2

Duns Number: 315666321

Premarket Exempt : No

Product Code : ELM

Prescription Use : Yes

Device Count : 1

FLEXITIME DYNAMIX MONO REFILL(1X2X380ml) - J014400039900 Catalog Number : 40003990

Device Description : Material, Impression

Device Class : 2

Duns Number: 315666321

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

FLEXITIME DYNAMIX HT REFILL 1X(2X380ml) - J014400039910 Catalog Number : 40003991

Device Description : Material, Impression

Device Class : 2

Duns Number: 315666321

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

FLEXITIME DYNAMIX PUTTY REFILL1X(2X380ml - J014400039920 Catalog Number : 40003992

Device Description : Material, Impression

Device Class : 2

Duns Number: 315666321

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

DYNAMIX MIXING TIPS (1 X 50) - J014400043530 Catalog Number : 40004353

Device Description : Syringe, restortative and impression material

Device Class : 1

Duns Number: 315666321

Premarket Exempt : Yes

Product Code : EID

Prescription Use : Yes

Device Count : 1

FLEXITIME LIGHT FLOW 1 X (2 X 50 ML) - J014400050400 Catalog Number : 40005040

Device Description : Material, Impression

Device Class : 2

Duns Number: 315666321

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

FLEXITIME MEDIUM FLOW 1 X (2 X 50 ML) - J014400050410 Catalog Number : 40005041

Device Description : Material, Impression

Device Class : 2

Duns Number: 315666321

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

Mondial living Mould Chart A2 - J014400055030 Catalog Number : 40005503

Device Class : 2

Duns Number: 315666321

Premarket Exempt : No

Product Code : ELM

Prescription Use : Yes

Device Count : 1

Mondial living Mould Chart B1 - J014400055040 Catalog Number : 40005504

Device Class : 2

Duns Number: 315666321

Premarket Exempt : No

Product Code : ELM

Prescription Use : Yes

Device Count : 1

Artic 6 Living Mould Chart B1 - J014400055100 Catalog Number : 40005510

Device Class : 2

Duns Number: 315666321

Premarket Exempt : No

Product Code : ELM

Prescription Use : Yes

Device Count : 1

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