Skip to content

Primodent

by Polident d.o.o. Industrija dentalnih proizvodov 803 variants

Ref PRV.32B3Model Type 1/Type 2

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 23 Oct 2026. What this means

Overview

Discover the innovative Polident d.o.o. Industrija dentalnih proizvodov Primodent device, a groundbreaking solution for artificial polymer teeth with advanced features and seamless integration into your daily oral care routine.

Regulatory status

as of registry sync 23 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  • Withdrawn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

Model / Reference
Type 1/Type 2, PRV.32B3
Primary DI / UDI-DI
+EPOLPRV32B30C
Basic UDI-DI
++EPOLAPTKB
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

Other devices from Polident d.o.o. Industrija dentalnih proizvodov

  • Policold

    Class IIa

  • K-30 S

    Class IIa

  • Polirepar S

    Class IIa

  • Policold

    Class IIa

  • Polirepar S

    Class IIa

  • K-30 S

    Class IIa

See all devices from Polident d.o.o. Industrija dentalnih proizvodov →

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