DETAX GmbH & Co. KG

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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

Crown And Bridge, Temporary, Resin (EBG) (6) Maintainer, Space Preformed, Orthodontic (DYT) (2) Positioner, Tooth, Preformed (KMY) (2) Hearing Aid, Air-Conduction, Prescription (ESD) (1) Resin, Denture, Relining, Repairing, Rebasing (EBI) (1)

Premarket Exempt

No Yes

Clear

FREEPRINT temp A1 385 500g - EDET020141 Catalog Number :

Device Class : 2

Duns Number: 317099257

Premarket Exempt : No

Product Code : EBG

Prescription Use : No

Device Count : 1

Freeprint denture pink 385 1000g - EDET020401 Catalog Number :

Device Class : 2

Duns Number: 317099257

Premarket Exempt : No

Product Code : EBI

Prescription Use : No

Device Count : 1

Freeprint Splint 2.0 385 1000g - EDET020761 Catalog Number :

Device Class : 1

Duns Number: 317099257

Premarket Exempt : Yes

Product Code : DYT, KMY

Prescription Use : No

Device Count : 1

Freeprint splint 2.0 385 500g - EDET020801 Catalog Number :

Device Class : 1

Duns Number: 317099257

Premarket Exempt : Yes

Product Code : KMY, DYT

Prescription Use : No

Device Count : 1

bioplast 40 shore 8 x 50ml - EDET020811 Catalog Number :

Device Class : 1

Duns Number: 317099257

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

tempofit duomix single bag A2 - EDET021061 Catalog Number :

Device Class : 2

Duns Number: 317099257

Premarket Exempt : No

Product Code : EBG

Prescription Use : No

Device Count : 1

FREEPRINT temp A2 385 500g - EDET021081 Catalog Number :

Device Class : 2

Duns Number: 317099257

Premarket Exempt : No

Product Code : EBG

Prescription Use : No

Device Count : 1

FREEPRINT temp A3 385 500g - EDET021191 Catalog Number :

Device Class : 2

Duns Number: 317099257

Premarket Exempt : No

Product Code : EBG

Prescription Use : No

Device Count : 1

FREEPRINT temp A1 385 1000g - EDET021201 Catalog Number :

Device Class : 2

Duns Number: 317099257

Premarket Exempt : No

Product Code : EBG

Prescription Use : No

Device Count : 1

FREEPRINT temp A2 385 1000g - EDET021301 Catalog Number :

Device Class : 2

Duns Number: 317099257

Premarket Exempt : No

Product Code : EBG

Prescription Use : No

Device Count : 1

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