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

Hearing Aid, Air-Conduction, Prescription (ESD) (3) Material, Impression Tray, Resin (EBH) (2) Syringe, Ent (KCP) (2) Syringe, Restorative And Impression Material (EID) (2) Resin, Denture, Relining, Repairing, Rebasing (EBI) (1)

Premarket Exempt

No Yes

Clear

mollosil plus Primer 5 ml - EDET024401 Catalog Number :

Device Class : 2

Duns Number: 317099257

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Ultraprint-Dental IBT UV 1000g - EDET024501 Catalog Number :

Device Class : 1

Duns Number: 317099257

Premarket Exempt : Yes

Product Code : EBH

Prescription Use : No

Device Count : 1

aquaplus colormix red 8 x 50 ml - EDET024511 Catalog Number :

Device Class : 1

Duns Number: 317099257

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

aquaplus colormix blue 8 x 50 ml - EDET024521 Catalog Number :

Device Class : 1

Duns Number: 317099257

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

green eco 2 x 800 g - EDET024871 Catalog Number :

Device Class : 1

Duns Number: 317099257

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

easy spare cylinder - EDET024921 Catalog Number :

Device Class : 1

Duns Number: 317099257

Premarket Exempt : Yes

Product Code : KCP

Prescription Use : No

Device Count : 1

freeprint tray 385 2.0 1000g - EDET025051 Catalog Number :

Device Class : 1

Duns Number: 317099257

Premarket Exempt : Yes

Product Code : EBH

Prescription Use : No

Device Count : 1

mixing cannulas quadro 25 pcs. - EDET025131 Catalog Number :

Device Class : 1

Duns Number: 317099257

Premarket Exempt : Yes

Product Code : KCP

Prescription Use : No

Device Count : 1

Mixing tip blue C&B 1:1 - EDET025261 Catalog Number :

Device Class : 1

Duns Number: 317099257

Premarket Exempt : Yes

Product Code : EID

Prescription Use : No

Device Count : 1

mixing cannulas brown 4:1 25 pcs - EDET025911 Catalog Number :

Device Class : 1

Duns Number: 317099257

Premarket Exempt : Yes

Product Code : EID

Prescription Use : No

Device Count : 1

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