Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8030876

FEI Number

1000207287

Entity Name

Planmeca Oy

City/State/Country

Helsinki Uusimaa, FI

Establishment Address

Asentajankatu 6, Helsinki Uusimaa 00880, FI

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Planmeca Oy (Owner Number: 10023612)

Owner / Operator Contact Address

Asentajankatu 6, Helsinki, FI-18 00880, FI

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K060328

PMA Number

N/A

All Registered Proprietary Names

Planmeca SingLed Planmeca Viso Planmeca Viso G7 Planmeca Viso G5 Planmeca ProX Planmeca Emerald Planmeca Emerald S Cariosity; TIA Tip; Transillumination Accessory Tip Planmeca Solanna Planmeca Pro50 Chair Planmeca ProOne Planmeca ProSensor HD Planmeca ProMax 3D Plus Planmeca ProMax 3D Mid Planmeca ProMax 3D

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EAZ	Light, Operating, Dental	Dental	Class 1	872.4630	2007-12-05
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2024-01-08
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2007-12-05
NTK	Caries Detector, Laser Light, Transmission	Dental	Class 2	872.1745	2024-08-02
EAZ	Light, Operating, Dental	Dental	Class 1	872.4630	2017-08-28
NRU	Chair, Dental, Without Operative Unit	Dental	Class 1	872.6250	2022-12-07
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2007-12-05
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2009-11-12
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2011-03-29
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2007-12-05

Official Correspondent

Niina Vuorikallas

US Agent Details

Brett Hetherington Business: Planmeca U.S.A. Inc. Email: Brett.Hetherington@planmecausa.com Phone: (630) 5292300

Related Public Records

Same Entity

Planmeca Oy

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K991310	Villa Sistemi Medicali S.P.A.	EXPLOR-X 70	1999-06-18
K221008	Shanghai Handy Medical Equipment Co., Ltd.	HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)	2022-06-22
K160788	Ray Co., Ltd.	RIOScan (RPS500)	2016-04-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2015	Gendex Corp	2	eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC Product Usage: intraoral x-ray
Z-0016-2017	Panoramic Rental Corp.	2	Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.

Similar Registrations

Registration Number	Establishment Name	Location
3015703934	MEDFRUITION ELECTRONICS TECHNOLOGY CO., LTD	Foshan City Guangdong, CN
3014766731	TAKARA BELMONT CORPORATION, OSAKA FACTORY	OSAKA, JP
3023443842	HENAN BAISTRA MEDICAL DEVICES LIMITED	Zhengzhou Henan, CN
2031508	TPC ADVANCED TECHNOLOGY, INC.	City Industry, CA, US
3022226	FOREST DENTAL EQUIPMENT	HILLSBORO, OR, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8030876. Last updated year: 2026. Please use registration number 8030876 when referencing this establishment in official correspondence.