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Dmc-04

by DIGIMED Co., Ltd.

Ref DMC-04Model PROX

Dmc-04 is a hand-held intraoral dental x-ray system (EU MDD Class IIb; FDA Class II; FDA product code EHD, Unit, X-Ray, Extraoral With Timer) made by DigiMed Co., Ltd., registered in EUDAMED on 14 Oct 2024 (Basic UDI-DI B-08800021800007), cleared under FDA 510(k) K082167 on 26 Sep 2008 and listed in FDA GUDID since 7 Nov 2016 (UDI-DI 08800021800007), active as of 22 Oct 2026. One FDA recall is linked to it.

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

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K082167

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800021800007 Basic UDI-DI 08800021800007UDI-DIDate14 Oct 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08800021800007 UDI-DI Date7 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK082167 Date26 Sep 2008DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08800021800007 registered 14 Oct 2024 Active
  • FDA 510(k) K082167 decided 26 Sep 2008 Active
  • FDA GUDID UDI-DI 08800021800007 listed 7 Nov 2016 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2117-2025 FDA Class II initiated 19 Jun 2025

    Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.

Timeline

4 dated events

  1. Cleared FDA 510(k) K082167
  2. Listed FDA GUDID 08800021800007
  3. Registered EUDAMED B-08800021800007
  4. Recall initiated FDA recalls Z-2117-2025

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Prox
Generic name
Hand-held intraoral dental x-ray system, digital
Model / Ref / Catalog
PROX EUDAMED
DMC-04 EUDAMED
1 GUDID
DPC-04 GUDID
Primary DI / UDI-DI
08800021800007
Basic UDI-DI
B-08800021800007
510(k) Number
FDA product code
EHD
EMDN code
Z1103040102 Equipment for digital endoral radiology
GMDN term
Hand-held intraoral dental x-ray system, digital
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.1800
EU registration type
Legacy device (under a directive)
EU market of registration
Portugal
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
PROX
DMC-04
GUDID
1
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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-000016608
Authorised representative
KTR Europe GmbH DE-AR-000005685

Related devices

Category: Dental digital imaging sensor, intraoral

Similar devices in this category

Other devices filed under EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY.

Other devices from DigiMed Co., Ltd.

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    Class II

  • Xtg V 1

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  • XTG PRO 70 HYBRID Pro

    Class II

  • Diox-602 1 Open recall

    Class II

See all devices from DigiMed Co., Ltd. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)