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Splint Design R1.0

by 3Shape A/S

Ref R1.0

Splint Design R1.0 is a dental treatment application software (EU MDR Class IIa; FDA Class II; FDA product code PNN, Orthodontic Software) made by 3Shape A/S, registered in EUDAMED on 2 Jun 2026 (Basic UDI-DI 590272975004EW), cleared under FDA 510(k) K191911 on 27 Nov 2019 and listed in FDA GUDID since 23 Oct 2020 (UDI-DI 05902729753555), 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) K191911

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 Number590272975004EW Basic UDI-DI 05902729753555UDI-DIDate2 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05902729753555 UDI-DI Date23 Oct 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK191911 Date27 Nov 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 590272975004EW registered 2 Jun 2026 Active
  • FDA 510(k) K191911 decided 27 Nov 2019 Active
  • FDA GUDID UDI-DI 05902729753555 listed 23 Oct 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K191911
  2. Listed FDA GUDID 05902729753555
  3. Registered EUDAMED 590272975004EW

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  • Withdrawn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
Splint Design GUDID
Generic name
Dental treatment application software
Model / reference
R1.0
Primary DI / UDI-DI
05902729753555
Basic UDI-DI
590272975004EW
510(k) Number
FDA product code
PNN
EMDN code
Z12119082 Various dental stomatology instruments - software accessories
GMDN term
Dental treatment application software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.5470
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 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.

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

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)