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Solventum™ Durelon™

by Solventum Germany GmbH

Ref 38265

Solventum™ Durelon™ (38265) is a device classified as Class IIa in the EU and Class II in the US made by Solventum Germany GmbH, registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI 01979982761020000000035R6) and listed in FDA GUDID since 24 Oct 2026 (UDI-DI 00197998079931), active as of 9 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number01979982761020000000035R6 Basic UDI-DI 00197998079931UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00197998079931 UDI-DI Date24 Oct 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 01979982761020000000035R6 registered 4 Nov 2026 Active
  • FDA GUDID UDI-DI 00197998079931 listed 24 Oct 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00197998079931
  2. Registered EUDAMED 01979982761020000000035R6

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Solventum™ Durelon™ EUDAMED
Solventum GUDID
Generic name
Orthodontic bracket adhesive
Device name
Solventum Durelon
Model / Ref / Catalog
38265 EUDAMED
3017-645 GUDID
Primary DI / UDI-DI
00197998079931
Basic UDI-DI
01979982761020000000035R6
FDA product code
DYH
EMDN code
Q0101010299 Temporary and permanent dental restoration cements - other
GMDN term
Orthodontic bracket adhesive
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3750
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
38265
GUDID
3017-645
Device classEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
DE-MF-000038373

Similar devices in this category

Other devices filed under TEMPORARY AND PERMANENT DENTAL RESTORATION CEMENTS - OTHER.

Other devices from Solventum Germany GmbH

See all devices from Solventum Germany GmbH →

Properties

  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)