Skip to content

CAD/CAM Software 6834647

by SIRONA Dental Systems GmbH

Ref 6834647

CAD/CAM Software 6834647 is a device classified as Class I in the EU and Class II in the US made by SIRONA Dental Systems GmbH, registered in EUDAMED on 16 Oct 2026 (Basic UDI-DI B-+E27668346470) and listed in FDA GUDID since 23 Aug 2024 (UDI-DI +E27668346470), active as of 24 Oct 2026.

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

CE MDD

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/MDD EUDAMED NumberB-+E27668346470 Basic UDI-DI +E27668346470UDI-DIDate16 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+E27668346470 UDI-DI Date23 Aug 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-+E27668346470 registered 16 Oct 2026 Active
  • FDA GUDID UDI-DI +E27668346470 listed 23 Aug 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID +E27668346470
  2. Registered EUDAMED B-+E27668346470

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
CEREC SW 5.3 license EUDAMED
CAD/CAM Software GUDID
Generic name
CAD/CAM software
Model / Ref / Catalog
6834647
Primary DI / UDI-DI
+E27668346470 EUDAMED
E27668346470 GUDID
Basic UDI-DI
B-+E27668346470
FDA product code
PNP, NHA
EMDN code
Z11069092 Various digital bioimaging management instruments - medical device software
GMDN term
CAD/CAM software
Device class
Class I EUDAMED
Class II GUDID
Regulation number
872.3630
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+E27668346470
GUDID
E27668346470
Device classEUDAMED
Class I
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists +E27668346470; FDA GUDID lists E27668346470), so their flags are not compared. 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: CAD/CAM software

Similar devices in this category

Other devices filed under VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE.

Other devices from SIRONA Dental Systems GmbH

See all devices from SIRONA Dental Systems GmbH →

Properties

  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)