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Biodentine

by Septodont United States EUDAMED

Ref 245S-246S/5

EMDN Q01010199

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-FR-MF-00001699200031PE Basic UDI-DIDate15 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Biodentine™
Model / Reference
245S-246S/5
Primary DI / UDI-DI
D-FR-MF-00001699200031PE
Basic UDI-DI
B-FR-MF-00001699200031PE
EMDN Code
Q01010199 Dental restoration devices - other
Device Class
Class III
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
FR-MF-000016992

Other devices from Septodont

See all devices from Septodont →

Properties & raw data

Show properties, registry sources and raw records
  • Implantable
Other properties (10)
  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED D-FR-MF-00001699200031PE|B-FR-MF-00001699200031PE 61 fields · synced 24 Oct 2026