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Organic PMMA FD

by Polident d.o.o. Industrija dentalnih proizvodov 7 variants

Ref 67-3829, 67-3837, 67-3825, 67-3384, 67-3390, 67-3819, 67-3395, 67-3805, 67-3391, 67-3383, 67-3393, 67-3394, 67-3827, 67-3380, 67-3385, 67-3824

Active European Union

CE MDR

Valid until

29 Jul 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR-0014 Date24 Jun 2026IssuedStatusActive expires 29 Jul 2029

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Pink Cad/Cam Disc
Model / Reference
67-3829, 67-3837, 67-3825, 67-3384, 67-3390, 67-3819, 67-3395, 67-3805, 67-3391, 67-3383, 67-3393, 67-3394, 67-3827, 67-3380, 67-3385, 67-3824
Primary DI / UDI-DI
+EPOL6738290V, +EPOL6738370U, +EPOL6738250R, +EPOL6733840R, +EPOL6733900O, +EPOL6738190U, +EPOL6733950T, +EPOL6738050P, +EPOL6733910P, +EPOL6733830Q, +EPOL6733930R, +EPOL6733940S, +EPOL6738270T, +EPOL6733800N, +EPOL6733850S, +EPOL6738240Q
Basic UDI-DI
++EPOLPINKCCJJ
Direct Marketing DI
+EPOL6738290V
+EPOL6738370U
+EPOL6738250R
+EPOL6733840R
+EPOL6733900O
+EPOL6738190U
+EPOL6733950T
+EPOL6738050P
+EPOL6733910P
+EPOL6733830Q
+EPOL6733930R
+EPOL6733940S
+EPOL6738270T
+EPOL6733800N
+EPOL6733850S
+EPOL6738240Q
EMDN Code
Q010699 Materials for the preparation of custom-made dental devices - other
Device Class
Class IIa
EU market of registration
Slovenia

Manufacturer details

EUDAMED SRN
SI-MF-000000740

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Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No