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Trios 5 L1-2

by 3Shape TRIOS A/S

Ref L1-2

Trios 5 L1-2 is a device classified as Class I in the EU and Class II in the US made by 3Shape TRIOS A/S, registered in EUDAMED on 6 Aug 2026 (Basic UDI-DI 590272975015F3), cleared under FDA 510(k) K221249 on 16 Sep 2022 and listed in FDA GUDID since 26 Sep 2022 (UDI-DI 05902729753739), 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) K221249

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 Number590272975015F3 Basic UDI-DI 05902729753739UDI-DIDate6 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05902729753739 UDI-DI Date26 Sep 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK221249 Date16 Sep 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 590272975015F3 registered 6 Aug 2026 Active
  • FDA 510(k) K221249 decided 16 Sep 2022 Active
  • FDA GUDID UDI-DI 05902729753739 listed 26 Sep 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K221249
  2. Listed FDA GUDID 05902729753739
  3. Registered EUDAMED 590272975015F3

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  • Withdrawn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
3Shape EUDAMED
Trios 5 GUDID
Generic name
Intraoral optical scanning system
Model / reference
L1-2
Primary DI / UDI-DI
05902729753739
Basic UDI-DI
590272975015F3
510(k) Number
FDA product code
NBL
EMDN code
Q0199 Odontology devices - other
GMDN term
Intraoral optical scanning system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
872.1745
EU registration type
Standard device
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution

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: Intraoral optical scanning system

Cleared under the same submission (K221249)

and 4 more cleared under K221249

Similar devices in this category

Other devices filed under ODONTOLOGY DEVICES - OTHER.

Other devices from 3Shape TRIOS A/S

  • 3Shape

    Class I

  • Trios Move Pro C4.2

    Class II

  • TRIOS Dx R1.1

    Class II

  • TRIOS Dx R1.2

    Class II

See all devices from 3Shape TRIOS A/S →

Properties

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