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Planmeca ProOne

by Planmeca Oy

Ref 30010469

Planmeca ProOne (30010469) is a device classified as Class IIb in the EU and Class II in the US made by Planmeca Oy, registered in EUDAMED on 28 Nov 2021 (Basic UDI-DI B-06430035420322) with CE/MDR certificate FI23/00000059 valid until 26 Jun 2030, cleared under FDA 510(k) K072244 on 21 Sep 2007 and listed in FDA GUDID since 10 Aug 2016 (UDI-DI 06430035420322), active as of 25 Oct 2026.

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

CE MDR CE MDD 510(k)

Valid until

26 Jun 2030

CE MDR certificate

FDA recalls

None found

in data synced 25 Oct 2026

Documents

1 certificate

Certifier SGS FIMKO OY

510(k) K072244↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberFI23/00000059 Date17 Sep 2025IssuedStatusActive expires 26 Jun 2030
European UnionCE/MDD EUDAMED NumberB-06430035420322 Basic UDI-DI 06430035420322UDI-DIDate28 Nov 2021RegisteredStatusActive
United StatesGUDID listing GUDID Number06430035420322 UDI-DI Date10 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK072244 Date21 Sep 2007IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-06430035420322 registered 28 Nov 2021 Active· +2 more in the status table
  • FDA 510(k) K072244 decided 21 Sep 2007 Active
  • FDA GUDID UDI-DI 06430035420322 listed 10 Aug 2016 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • FI23/00000059 Active Supplemented

    Quality management system EU MDR

    Certifier
    SGS FIMKO OY 0598
    Issued
    17 Sep 2025
    Expires
    26 Jun 2030
    Reason
    Other

Timeline

5 dated events

  1. Cleared FDA 510(k) K072244
  2. Listed FDA GUDID 06430035420322
  3. Registered EUDAMED B-06430035420322
  4. Certificate issued EUDAMED FI23/00000059
  5. Certificate expires EUDAMED FI23/00000059

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  • Withdrawn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 · 510(k) · GUDID

Generic name
Stationary panoramic dental x-ray system, digital
Model / Ref / Catalog
30010469, ProOne, 30054727, 30054735
Primary DI / UDI-DI
06430035420322
Basic UDI-DI
B-06430035420322, 6430035420175U
510(k) Number
FDA product code
MUH
EMDN code
Z11030302, Z11030380
GMDN term
Stationary panoramic dental x-ray system, digital
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.1800
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
30010469
GUDID
ProOne
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
FI-MF-000006499

Similar devices in this category

Other devices filed under INSTRUMENTS FOR EXTRAORAL DENTAL RADIOLOGY.

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Properties

  • Prescription use
  • Over-the-counter
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)