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D-Lux+ Regular Kit

by DiaDent Group International

Part of a family of 11 devices: see the family page

Ref REGULAR KIT / 4008-1001

D-Lux+ Regular Kit (4008-1001) is a device classified as Class I in the EU and Class II in the US made by DiaDent Group International, registered in EUDAMED on 15 May 2026 (Basic UDI-DI 88063835DLFP), cleared under FDA 510(k) K200809 on 7 Aug 2020 and listed in FDA GUDID since 19 Aug 2021 (UDI-DI 08806383568760), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K200809

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88063835DLFP Basic UDI-DI 08806383568760UDI-DIDate15 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08806383568760 UDI-DI Date19 Aug 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK200809 Date7 Aug 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 88063835DLFP registered 15 May 2026 Active
  • FDA 510(k) K200809 decided 7 Aug 2020 Active
  • FDA GUDID UDI-DI 08806383568760 listed 19 Aug 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K200809
  2. Listed FDA GUDID 08806383568760
  3. Registered EUDAMED 88063835DLFP

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  • Withdrawn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
D-Lux+
Generic name
Dental/surgical polymerization lamp
Model / Ref / Catalog
REGULAR KIT / 4008-1001 EUDAMED
REGULAR KIT GUDID
4008-1001 GUDID
Primary DI / UDI-DI
08806383568760
Basic UDI-DI
88063835DLFP
FDA product code
EBZ
EMDN code
Q019008 Dentinal desensitisers
GMDN term
Dental/surgical polymerization lamp
Device class
Class I EUDAMED
Class II GUDID
Regulation number
872.6070
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
REGULAR KIT / 4008-1001
GUDID
REGULAR KIT
Device classEUDAMED
Class I
GUDID
Class II

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 (K200809)

and 5 more cleared under K200809

Similar devices in this category

Other devices filed under DENTINAL DESENSITISERS.

Other devices from DiaDent Group International

See all devices from DiaDent Group International →

Properties

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