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Solventum™ Filtek™

by Solventum US LLC 44 variants

Ref 8021A3.5

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number01979988401020000000130NG Basic UDI-DI 00197998097126UDI-DIDate1 Sep 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  • Withdrawn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
Solventum™ Filtek™ Z500 Universal Restorative
Model / Reference
8021A3.5
Primary DI / UDI-DI
00197998097126
Basic UDI-DI
01979988401020000000130NG
Unit of Use DI
00197998097119
EMDN Code
Q01010103 Dental restorative composites
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000044314
Authorised representative
Solventum Germany GmbH DE-AR-000043541

Other devices from Solventum US LLC

See all devices from Solventum US LLC →

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