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ScanPost AT TX 6598119

by SIRONA Dental Systems GmbH

Ref 6598119

ScanPost AT TX 6598119 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 9 Oct 2026 (Basic UDI-DI B-+E27665981192) and listed in FDA GUDID since 22 May 2023 (UDI-DI +E27665981192), 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-+E27665981192 Basic UDI-DI +E27665981192UDI-DIDate9 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+E27665981192 UDI-DI Date22 May 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-+E27665981192 registered 9 Oct 2026 Active
  • FDA GUDID UDI-DI +E27665981192 listed 22 May 2023 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID +E27665981192
  2. Registered EUDAMED B-+E27665981192

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  • Withdrawn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
ScanPost AT TX
Generic name
Dental implant suprastructure, permanent, preformed
Model / Ref / Catalog
6598119
Primary DI / UDI-DI
+E27665981192 EUDAMED
E27665981192 GUDID
Basic UDI-DI
B-+E27665981192
FDA product code
NHA
EMDN code
P01020180 Dental implants - accessories
GMDN term
Dental implant suprastructure, permanent, preformed
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 · 3 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+E27665981192
GUDID
E27665981192
Device classEUDAMED
Class I
GUDID
Class II
ImplantableEUDAMED
No
GUDID
Yes

The registries describe this device under different primary UDI-DIs (EUDAMED lists +E27665981192; FDA GUDID lists E27665981192), 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.

Similar devices in this category

Other devices filed under DENTAL IMPLANTS - ACCESSORIES.

Other devices from SIRONA Dental Systems GmbH

See all devices from SIRONA Dental Systems GmbH →

Properties

  • Single use
  • Implantable NoEUDAMEDYesGUDID
  • Lot / batch number
Other properties (22, all answered No)