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Tempo-Cad

by On Dent Tibbi Malz. Dis Pro Ith. Ihr. San. ve Tic. Ltd. Sti

Ref 980108-SMCModel PMMA Disc and Block

Active European Union

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number86804455001US Basic UDI-DI 08680445517664UDI-DIDate21 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
PMMA Disc and Block
Model / Reference
PMMA Disc and Block, 980108-SMC
Primary DI / UDI-DI
08680445517664
Basic UDI-DI
86804455001US
EMDN Code
Q01020605 Temporary dental prostheses
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
TR-MF-000040516

Other devices from On Dent Tibbi Malz. Dis Pro Ith. Ihr. San. ve Tic. Ltd. Sti

Properties

  • Implantable

Other properties (12)

  • Sterile: 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