Skip to content

Planmeca Compact i5

by Planmeca Oy

Ref 30013450

Planmeca Compact i5 (30013450) is a device classified as Class IIa in the EU and Class I in the US made by Planmeca Oy, registered in EUDAMED on 25 Jun 2024 (Basic UDI-DI 6430035420075R) with CE/MDR certificate FI23/00000059 valid until 26 Jun 2030, cleared under FDA 510(k) K961420 on 10 Sep 1996 and listed in FDA GUDID since 2 Jan 2019 (UDI-DI 06430035420575), active as of 7 Nov 2026.

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

CE MDR 510(k)

Valid until

26 Jun 2030

CE MDR certificate

FDA recalls

None found

in data synced 7 Nov 2026

Documents

1 certificate

Certifier SGS FIMKO OY

510(k) K961420

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberFI23/00000059 Date17 Sep 2025IssuedStatusActive expires 26 Jun 2030
United StatesGUDID listing GUDID Number06430035420575 UDI-DI Date2 Jan 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK961420 Date10 Sep 1996DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 6430035420075R registered 25 Jun 2024 Active· +1 more in the status table
  • FDA 510(k) K961420 decided 10 Sep 1996 Active
  • FDA GUDID UDI-DI 06430035420575 listed 2 Jan 2019 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) K961420
  2. Listed FDA GUDID 06430035420575
  3. Registered EUDAMED 6430035420075R
  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  • Withdrawn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 Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Planmeca Compact i5 EUDAMED
Planmeca Compact GUDID
Generic name
Dental delivery system
Model / Ref / Catalog
30013450, i5, 30015629, 30015630, 30015632, 30015633
Primary DI / UDI-DI
06430035420575
Basic UDI-DI
6430035420075R
510(k) Number
FDA product code
EIA
EMDN code
Z12110101 Dental treatment units
GMDN term
Dental delivery system
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.6640
EU registration type
Standard device
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
30013450
GUDID
i5
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I 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 DENTAL TREATMENT UNITS.

Other devices from Planmeca Oy

See all devices from Planmeca Oy →

Properties

  • Serial number
  • Manufacturing date
Other properties (23, all answered No)