Data / Medical devices / Finland / Planmeca Oy

Planmeca Oy: FDA-registered device maker in Helsinki Uusimaa, Finland, 11 510(k) clearances

Name: Planmeca Oy FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Planmeca Oy is registered with the FDA (registration 8030876) in Helsinki Uusimaa, Finland. It lists 9 device types. The FDA files 11 510(k) clearances under its listings, the newest dated December 28, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 8030876
FEI number: 1000207287
Address: Asentajankatu 6, Helsinki Uusimaa, Finland, 00880
Owner or operator: Planmeca Oy (10023612)
Roles: Manufacturer
First device listed: December 5, 2007
Registered through: 2026
Brand names listed: Cariosity; TIA Tip; Transillumination Accessory Tip, Planmeca Compact i, Planmeca Emerald, Planmeca Emerald S, Planmeca Onyx, Planmeca Pro50 Chair, Planmeca ProMax, Planmeca ProMax 3D and more

Devices it lists

Device	Product code	Class	Role	Source
Chair, Dental, Without Operative Unit	NRU	1	Manufacturer	accessdata.fda.gov
Light Transmission Caries Detector	NTK	2	Manufacturer	accessdata.fda.gov
Light, Operating, Dental	EAZ	1	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	NOF	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Extraoral Source, Digital	MUH	2	Manufacturer	accessdata.fda.gov
Unit, Operative Dental	EIA	1	Manufacturer	accessdata.fda.gov
Unit, X-Ray, Extraoral With Timer	EHD	2	Manufacturer	accessdata.fda.gov
X-Ray, Tomography, Computed, Dental	OAS	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 28, 2023	K230985	Planmeca Viso	OAS	Substantially Equivalent	Planmeca Oy	accessdata.fda.gov
April 29, 2022	K213482	TIA Tip, Cariosity, Transillumination Accessory Tip	NTK	Substantially Equivalent	D4D Technologies, LLC	accessdata.fda.gov
December 2, 2020	K200572	Planmeca Romexis	LLZ	Substantially Equivalent	Planmeca Oy	accessdata.fda.gov
March 17, 2011	K103689	PLANMECA PROMAX 3D MID	MUH	Substantially Equivalent	Planmeca Oy	accessdata.fda.gov
July 29, 2009	K091197	PLANMECA PROSENSOR	EHD	Substantially Equivalent	Planmeca Oy	accessdata.fda.gov
September 21, 2007	K072244	PLANMECA PROONE	MUH	Substantially Equivalent	Planmeca Oy	accessdata.fda.gov
March 15, 2006	K060328	PLANMECA PROMAX 3D	MUH	Substantially Equivalent	Planmeca Oy	accessdata.fda.gov
June 24, 2005	K051464	PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL)	EHD	Substantially Equivalent	Planmeca Oy	accessdata.fda.gov
September 10, 1996	K961420	PROSTYLE COMPACT	EIA	Substantially Equivalent	Planmeca Oy	accessdata.fda.gov
December 11, 1995	K955429	PROSTYLE INTRA	EHD	Substantially Equivalent	Planmeca Oy	accessdata.fda.gov
December 21, 1992	K923462	DELIGHT	EAZ	Substantially Equivalent	Planmeca USA, Inc.	accessdata.fda.gov

Compare with other makers

Updated December 28, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.