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D-Lux+ Disposable Sheath

by DiaDent Group International

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

Ref DISPOSABLE SHEATH / 4008-1170

D-Lux+ Disposable Sheath (4008-1170) 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 08806383568845), active as of 7 Nov 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 7 Nov 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K200809

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88063835DLFP Basic UDI-DI 08806383568845UDI-DIDate15 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08806383568845 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 08806383568845 listed 19 Aug 2021 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) K200809
  2. Listed FDA GUDID 08806383568845
  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  • Withdrawn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
DISPOSABLE SHEATH / 4008-1170 EUDAMED
DISPOSABLE SHEATH GUDID
4008-1170 GUDID
Primary DI / UDI-DI
08806383568845
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
DISPOSABLE SHEATH / 4008-1170
GUDID
DISPOSABLE SHEATH
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

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