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Solventum™ Filtek™

by Solventum US LLC 55 variants

Ref 4861U

Solventum™ Filtek™ (4861U) is a Class IIa device made by Solventum US LLC, registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI 01979988401020000000114NJ), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

No date given

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

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number01979988401020000000114NJ Basic UDI-DI 00197998342875UDI-DIDate28 Oct 2026RegisteredStatusActive

Official records

  • EUDAMED public site Basic UDI-DI 01979988401020000000114NJ — open Devices and search for it

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Solventum™ Filtek™ Bulk Fill Flowable Restorative
Model / reference
4861U
Primary DI / UDI-DI
00197998342875
Basic UDI-DI
01979988401020000000114NJ
Unit of use DI
00197998342868
EMDN code
Q01010103 Dental restorative composites
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

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

Similar devices in this category

Other devices filed under DENTAL RESTORATIVE COMPOSITES.

Other devices from Solventum US LLC

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Properties

  • Implantable
Other properties (13, all answered No)