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Planmeca Romexis 4

by Planmeca Oy

Planmeca Romexis 4 is a Class II device made by Planmeca Oy, cleared under FDA 510(k) K140713 on 16 Jun 2014, registered in EUDAMED and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 06430035420254), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K140713

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06430035420254 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK140713 Date16 Jun 2014IssuedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K140713 decided 16 Jun 2014 Active
  • EUDAMED Active· +1 more in the status table
  • FDA GUDID UDI-DI 06430035420254 listed 19 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K140713
  2. Listed FDA GUDID 06430035420254

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Planmeca Romexis
Generic name
Panoramic/tomographic dental x-ray system application software
Model / reference
4
Primary DI / UDI-DI
06430035420254
510(k) Number
FDA product code
LLZ
GMDN term
Panoramic/tomographic dental x-ray system application software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Panoramic/tomographic dental x-ray system application software

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

Other devices from Planmeca Oy

See all devices from Planmeca Oy →

Properties

  • Over-the-counter
  • Lot / batch number
Other properties (13, all answered No)