Dental Device Guide
Add your company

Manufacturer registered with FDA

Planmeca Oy

Helsinki, Finland. Lists 8 dental device types with FDA across 1 registered establishment, and holds 25 510(k) clearances as applicant.

FDA owner/operator10023612Manufacturer1 clearance in five years
Device types listed
8
Brands and models
21
510(k) clearances
251993–2023
Markets registered in
15309 registrations outside the US
Establishments
1Finland
1993: 11995: 21996: 21997: 41998: 11999: 12000: 42001: 12005: 12006: 12007: 12009: 12010: 12011: 12016: 12018: 12023: 11990200020102020

510(k) clearances per year, 1990–2026

Registered in 15 markets

Where regulators' registries name Planmeca Oy as the manufacturer or the registration holder of a device.

All markets
United States: 8 device types listedCanada: 112 registrationsSouth Korea: 34 registrationsEuropean Union: 33 registrationsTaiwan: 28 registrationsUnited Kingdom: 20 registrationsCosta Rica: 16 registrationsAustralia: 14 registrationsSaudi Arabia: 13 registrationsSerbia: 9 registrationsIsrael: 8 registrationsChina: 7 registrationsPeru: 7 registrationsHong Kong: 5 registrationsBrazil: 3 registrations
RegisteredHome: FinlandOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerPlanmeca Oy25 clearances1993–2023Below
CanadaHealth CanadaRegistration holderPLANMECA OY1122004–2026Pure Global AI
South KoreaMFDSManufacturerPLANMECA OYPlanmeca Oy · PLANMECA Oy · +2341998–2019Pure Global AI
European UnionEUDAMEDManufacturerPlanmeca Oy33—Pure Global AI
TaiwanTFDAManufacturerPLANMECA OY281989–2026Pure Global AI
United KingdomMHRAManufacturerPlanmeca Oy20—Pure Global AI
Costa RicaMinisterio de SaludManufacturerPlanmeca Oy16—Pure Global AI
AustraliaTGAManufacturerPlanmeca Oy142004–2025Pure Global AI
Saudi ArabiaSFDAManufacturerPlanmeca Oy13—Pure Global AI
SerbiaALIMSManufacturerPlanmeca Oy92021–2026Pure Global AI
IsraelAMARManufacturerPlanmeca Oy8—Pure Global AI
ChinaNMPARegistration holder普兰梅卡公司Planmeca Oy普兰梅卡公司PLANMECA OY7—Pure Global AI
PeruDIGEMIDManufacturerPLANMECA OY72018–2026Pure Global AI
Hong KongMDDManufacturerPlanmeca Oy52026–2026Pure Global AI
BrazilANVISAManufacturerPLANMECA OY32018–2023Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What Planmeca Oy currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Digital Extraoral Source X-Ray SystemMUH · Class 2Dental X-ray unitsMaker
Planmeca ProMaxPlanmeca ProMax 3DPlanmeca ProMax 3D MidPlanmeca ProMax 3D PlusPlanmeca ProOne
2007
Extraoral with Timer X-Ray UnitEHD · Class 2Dental X-ray unitsMaker
Planmeca ProMaxPlanmeca ProSensor HDPlanmeca ProX
2007
Dental Operating LightEAZ · Class 1Dental operating lightsMaker
Planmeca SingLedPlanmeca Solanna
2007
Operative Dental UnitEIA · Class 1Dental chairs & operative unitsMaker
Planmeca Compact i
2007
Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2Intraoral scannersMaker
Planmeca EmeraldPlanmeca Emerald SPlanmeca Onyx
2015
Dental Chair without Operative UnitNRU · Class 1Dental chairs & operative unitsMaker
Planmeca Pro50 Chair
2022
Light Transmission Caries DetectorNTK · Class 2Caries detection devicesMaker
Cariosity; TIA Tip; Transillumination Accessory TipPlanmeca EmeraldPlanmeca Emerald S
2024
Dental Computed Tomography X-RayOAS · Class 2Dental CBCTMaker
Planmeca VisoPlanmeca Viso G5Planmeca Viso G7
2024

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Planmeca Oy as the applicant.

Decided510(k)DeviceDevice type
28 Dec 2023K230985Planmeca VisoOAS Dental Computed Tomography X-Ray
13 Sep 2018K181576Planmeca VisoOAS Dental Computed Tomography X-Ray
20 May 2016K160506Planmeca ProMax 3D Max, Planmeca MaximityOAS Dental Computed Tomography X-Ray
17 Mar 2011K103689PLANMECA PROMAX 3D MIDMUH Digital Extraoral Source X-Ray System
12 May 2010K093590PLANMECA PROMAX 3D MAXMUH Digital Extraoral Source X-Ray System
29 Jul 2009K091197PLANMECA PROSENSOREHD Extraoral with Timer X-Ray Unit
21 Sep 2007K072244PLANMECA PROONEMUH Digital Extraoral Source X-Ray System
15 Mar 2006K060328PLANMECA PROMAX 3DMUH Digital Extraoral Source X-Ray System
24 Jun 2005K051464PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL)EHD Extraoral with Timer X-Ray Unit
29 Jun 2001K011619PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTATEHD Extraoral with Timer X-Ray Unit
3 May 2000K000771DIMAX 2EHD Extraoral with Timer X-Ray Unit
28 Apr 2000K000428DIXI 2EHD Extraoral with Timer X-Ray Unit
18 Apr 2000K000163PM 2002 PROLINE/AECEHD Extraoral with Timer X-Ray Unit
31 Mar 2000K000454DIMEX 2MUH Digital Extraoral Source X-Ray System
26 Jan 1999K984013PLANMECA INTRACAM STATIONEIA Operative Dental Unit
17 Apr 1998K980581PLANMECA DIXI, DIGITAL INTRAORAL X-RAY IMAGING SYSTEMEHD Extraoral with Timer X-Ray Unit
5 Aug 1997K970812PM 2002 CC PROLINEEHD Extraoral with Timer X-Ray Unit
20 Jun 1997K972033PLANMECA INTRACAMEIA Operative Dental Unit
1 Apr 1997K970975PROSTYLE INTRAEHD Extraoral with Timer X-Ray Unit
26 Feb 1997K970263PM 2002 CC PROLINEEHD Extraoral with Timer X-Ray Unit
24 Oct 1996K963209PROSTYLE COMPACTKLC Dental Chair with Operative Unit
10 Sep 1996K961420PROSTYLE COMPACTEIA Operative Dental Unit
11 Dec 1995K955429PROSTYLE INTRAEHD Extraoral with Timer X-Ray Unit
7 Oct 1995K952763PANORAMIC X-RAY UNIT (MODIFICATION)EHD Extraoral with Timer X-Ray Unit
15 Dec 1993K934063PANORAMIC X-RAY UNITS, MODIFICATIONEHD Extraoral with Timer X-Ray Unit

Also lists devices cleared under other names

Planmeca Oy lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: D4D Technologies, LLC (1), Planmeca USA, Inc. (1).

Decided510(k)DeviceApplicantDevice type
29 Apr 2022K213482TIA Tip, Cariosity, Transillumination Accessory TipD4D Technologies, LLCNTK Light Transmission Caries Detector
21 Dec 1992K923462DELIGHTPlanmeca USA, Inc.EAZ Dental Operating Light

Registered establishments

EstablishmentLocationWhat it does
Planmeca OyFDA reg. 8030876Helsinki Uusimaa, FinlandManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10023612). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.