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Ledex Wl-090

by Dentmate Technology Co., Ltd.

Ref WL-090

Ledex Wl-090 is a device classified as Class I in the EU and Class II in the US made by Dentmate Technology Co., Ltd., registered in EUDAMED on 11 Jul 2026 (Basic UDI-DI 4719873920457AT), cleared under FDA 510(k) K131042 on 3 Oct 2013 and listed in FDA GUDID since 17 Jul 2019 (UDI-DI 04719873920457), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K131042

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4719873920457AT Basic UDI-DI 04719873920457UDI-DIDate11 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04719873920457 UDI-DI Date17 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK131042 Date3 Oct 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4719873920457AT registered 11 Jul 2026 Active
  • FDA 510(k) K131042 decided 3 Oct 2013 Active
  • FDA GUDID UDI-DI 04719873920457 listed 17 Jul 2019 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

3 dated events

  1. Cleared FDA 510(k) K131042
  2. Listed FDA GUDID 04719873920457
  3. Registered EUDAMED 4719873920457AT

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Ledex
Generic name
Dental/surgical polymerization lamp
Device name
Dental Curing Light
Model / reference
WL-090
Primary DI / UDI-DI
04719873920457 EUDAMED
04719873920471 GUDID
Basic UDI-DI
4719873920457AT
Direct marketing DI
04719873920457
510(k) Number
FDA product code
EBZ
EMDN code
Q01010199 Dental restoration devices - other
GMDN term
Dental/surgical polymerization lamp
Device class
Class I EUDAMED
Class II GUDID
Regulation number
872.6070
System or procedure pack
Procedure pack which is a device in itself
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
04719873920457
GUDID
04719873920471
Device classEUDAMED
Class I
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 04719873920457; FDA GUDID lists 04719873920471), so their flags are not compared. Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Dental/surgical polymerization lamp

Cleared under the same submission (K131042)

Similar devices in this category

Other devices filed under DENTAL RESTORATION DEVICES - OTHER.

Other devices from Dentmate Technology Co., Ltd.

See all devices from Dentmate Technology Co., Ltd. →

Properties

  • Single use
  • Prescription use
  • Serial number
Other properties (22, all answered No)