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Will3D

by HDX WILL Corp.

Ref CNW312Model Will3D

Will3D (CNW312) is a device classified as Class IIa in the EU and Class II in the US made by Hdx Will Corp., registered in EUDAMED on 3 May 2022 (Basic UDI-DI 88000052004LM), cleared under FDA 510(k) K211114 on 15 Dec 2021 (1 earlier submission) and listed in FDA GUDID since 21 Dec 2021 (UDI-DI 08800005200298), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K211114↗

+1 more

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88000052004LM Basic UDI-DI 08800005200298UDI-DIDate3 May 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number08800005200298 UDI-DI Date21 Dec 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK211114 Date15 Dec 2021IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 88000052004LM registered 3 May 2022 Active
  • FDA 510(k) K211114 decided 15 Dec 2021 Active· +1 more in the status table
  • FDA GUDID UDI-DI 08800005200298 listed 21 Dec 2021 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K170180
  2. Cleared FDA 510(k) K211114
  3. Listed FDA GUDID 08800005200298
  4. Registered EUDAMED 88000052004LM

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Generic name
General-purpose dental x-ray system application software
Model / reference
Will3D, CNW312
Primary DI / UDI-DI
08800005200298
Basic UDI-DI
88000052004LM
510(k) Number
FDA product code
LLZ
EMDN code
Z11030392 Instruments for extraoral dental radiology - medical device software
GMDN term
General-purpose dental x-ray system application software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2050
Special device type
Software
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

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
KR-MF-000019877
Authorised representative
KTR Europe GmbH DE-AR-000005685

Similar devices in this category

Other devices filed under INSTRUMENTS FOR EXTRAORAL DENTAL RADIOLOGY - MEDICAL DEVICE SOFTWARE.

Other devices from Hdx Will Corp.

  • WillCeph Pro

    Class IIa

  • Xcam

    Class II

  • DENTRI Max DENTRI-Sα

    Class II

  • DENTRIα Series

    Class II

See all devices from Hdx Will Corp. →

Properties

  • Measuring function
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)