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Duray DC1001

by Beyes Dental Canada Inc

Ref DC1, Duray Scanner DC1Model DC1001

Duray DC1001 is a medical device (EU MDR Class I; FDA Class II; FDA product code MUH, System, X-Ray, Extraoral Source, Digital; EMDN category various dental stomatology instruments) made by Beyes Dental Canada Inc, registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI 9900103012908N), cleared under FDA 510(k) K212080 on 27 Sep 2021 and listed in FDA GUDID since 11 May 2023 (UDI-DI 00990010301290), 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) K212080

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 Number9900103012908N Basic UDI-DI 00990010301290UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00990010301290 UDI-DI Date11 May 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK212080 Date27 Sep 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 9900103012908N registered 4 Nov 2026 Active
  • FDA 510(k) K212080 decided 27 Sep 2021 Active
  • FDA GUDID UDI-DI 00990010301290 listed 11 May 2023 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) K212080
  2. Listed FDA GUDID 00990010301290
  3. Registered EUDAMED 9900103012908N

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  • Withdrawn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
Duray
Generic name
Dental computed radiography digital imaging scanner
Device name
Imaging Plate Scanner
Model / Ref / Catalog
DC1001, DC1, Duray Scanner DC1
Primary DI / UDI-DI
00990010301290
Basic UDI-DI
9900103012908N
Direct marketing DI
00990010301290
510(k) Number
FDA product code
MUH
EMDN code
Z12119099 Various dental stomatology instruments - other
GMDN term
Dental computed radiography digital imaging scanner
Device class
Class I EUDAMED
Class II GUDID
Regulation number
872.1800
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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 computed radiography digital imaging scanner

Cleared under the same submission (K212080)

Similar devices in this category

Other devices filed under VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - OTHER.

Other devices from Beyes Dental Canada Inc

  • Duray 2D

    Class II

  • Duray 3D

    Class II

  • Duray Art Plus

    Class II

  • Duray 2D Ceph

    Class II

See all devices from Beyes Dental Canada Inc →

Properties

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