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Implant Studio R1.4

by 3Shape A/S

Ref R1.4

Implant Studio R1.4 is a dental treatment application software (EU MDR Class IIb; FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by 3Shape A/S, registered in EUDAMED on 8 Oct 2026 (Basic UDI-DI 590272975001EQ) and listed in FDA GUDID since 27 Jul 2023 (UDI-DI 05902729753845), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number590272975001EQ Basic UDI-DI 05902729753845UDI-DIDate8 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05902729753845 UDI-DI Date27 Jul 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 590272975001EQ registered 8 Oct 2026 Active
  • FDA GUDID UDI-DI 05902729753845 listed 27 Jul 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05902729753845
  2. Registered EUDAMED 590272975001EQ

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
3Shape EUDAMED
Implant Studio GUDID
Generic name
Dental treatment application software
Model / reference
R1.4
Primary DI / UDI-DI
05902729753845
Basic UDI-DI
590272975001EQ
FDA product code
LLZ
EMDN code
Z12119082 Various dental stomatology instruments - software accessories
GMDN term
Dental treatment application software
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.2050
Special device type
Software
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 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.

Related devices

Category: Dental treatment application software

Similar devices in this category

Other devices filed under VARIOUS DENTAL STOMATOLOGY INSTRUMENTS.

Other devices from 3Shape A/S

See all devices from 3Shape A/S →

Properties

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