Planmeca Oy

Reg #: 8030876 · FEI: 1000207287 · Expires 2026

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Products

Proprietary Names

Establishment Types

Classifications

Registration Details

Registration Name: Planmeca Oy
Registration Number: 8030876
FEI Number: 1000207287
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: Asentajankatu 6
City: Helsinki Uusimaa
Country: FI

Regulatory Submissions

510(k) Number: K923462

Owner / Operator

Firm Name: Planmeca Oy
Operator Number: 10023612
Address: Asentajankatu 6
City: Helsinki
State: Uusimaa
Postal Code: 00880
Country: FI
Correspondent: Niina M Vuorikallas

US Agent

Business Name: Planmeca U.S.A. Inc.
Contact Name: Brett Hetherington
Address: 11727 Fruehauf Dr
City: Charlotte
State: NC
ZIP: 28273
Country: US
Email: [email protected]
Phone: 630 5292300 ext. 98772

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Light, Operating, Dental	EAZ	Class 1	Dental	No	2007-12-05
X-Ray, Tomography, Computed, Dental	OAS	Class 2	Radiology	No	2024-01-08
Unit, X-Ray, Extraoral With Timer	EHD	Class 2	Dental	No	2007-12-05
Caries Detector, Laser Light, Transmission	NTK	Class 2	Dental	No	2024-08-02
Chair, Dental, Without Operative Unit	NRU	Class 1	Dental	No	2022-12-07
System, X-Ray, Extraoral Source, Digital	MUH	Class 2	Dental	No	2007-12-05
System, Image Processing, Radiological	LLZ	Class 2	Radiology	No	2021-10-15
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	NOF	Class 2	Dental	No	2015-09-07
Unit, Operative Dental	EIA	Class 1	Dental	No	2007-12-05

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 Planmeca Romexis Planmeca ProMax Planmeca Compact i

Establishment Types

Manufacture Medical Device