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Simplant Version 18.5

by Dentsply Implants NV

Ref 54500277P185

Simplant Version 18.5 (54500277P185) is a device classified as Class IIa in the EU and Class II in the US made by Dentsply Implants NV, registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI 739253200183DE) and listed in FDA GUDID since 25 Apr 2019 (UDI-DI 07392532206269), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number739253200183DE Basic UDI-DI 07392532206269UDI-DIDate3 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07392532206269 UDI-DI Date25 Apr 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 739253200183DE registered 3 Nov 2026 Active
  • FDA GUDID UDI-DI 07392532206269 listed 25 Apr 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07392532206269
  2. Registered EUDAMED 739253200183DE

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  • Withdrawn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
SIMPLANT® Pro 18.5 EUDAMED
Simplant GUDID
Generic name
Panoramic/tomographic dental x-ray system application software
Device name
Simplant Software IIa Simplant Software
Model / Ref / Catalog
54500277P185, Version 18.5
Primary DI / UDI-DI
07392532206269
Basic UDI-DI
739253200183DE
FDA product code
LLZ
EMDN code
Z11030392 Instruments for extraoral dental radiology - medical device software
GMDN term
Panoramic/tomographic dental x-ray system application software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2050
Special device type
Software
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
54500277P185
GUDID
Version 18.5
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: Panoramic/tomographic dental x-ray system application software

Similar devices in this category

Other devices filed under INSTRUMENTS FOR EXTRAORAL DENTAL RADIOLOGY - MEDICAL DEVICE SOFTWARE.

Other devices from Dentsply Implants NV

See all devices from Dentsply Implants NV →

Properties

  • Measuring function
  • Prescription use
  • Manufacturing date
Other properties (22, all answered No)