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PalaXtreme

by KULZER GmbH 38 variants

Ref 000000000066070957

PalaXtreme (000000000066070957) is a Class IIa device made by KULZER GmbH, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI ++J0141209DEBM0699gAY), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++J0141209DEBM0699gAY Basic UDI-DI +J014660709570UDI-DIDate5 Nov 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
000000000066070957
Primary DI / UDI-DI
+J014660709570
Basic UDI-DI
++J0141209DEBM0699gAY
EMDN code
Q010699 Materials for the preparation of custom-made dental devices - other
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
DE-MF-000007705

Similar devices in this category

Other devices filed under MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES.

Other devices from KULZER GmbH

See all devices from KULZER GmbH →

Properties

Other properties (14, all answered No)