Data / Medical devices / Canada / Onvet Medical Canada Inc

Onvet Medical Canada Inc: FDA-registered device maker in TORONTO Ontario, Canada, 8 510(k) clearances

Name: Onvet Medical Canada Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Onvet Medical Canada Inc is registered with the FDA (registration 3030126955) in TORONTO Ontario, Canada. It lists 27 device types. The FDA files 8 510(k) clearances under its listings, the newest dated September 22, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3030126955
Address: 7-145 Select Ave, TORONTO Ontario, Canada, M1V5M8
Owner or operator: ONVET MEDICAL CANADA INC (10089540)
Roles: Manufacturer, Repackager or relabeler, Specification developer
First device listed: December 15, 2023
Registered through: 2026
Brand names listed: AMW AirPeak G100, G200, G200X;G300, G400,MT05;MT20; P100; AMW iTesla G500, G600, G700, G800,MT40, AMW-Stronic Series Ultrasonic Scaler, Advanced Film Reader, Aimax®-F Flim Holder; Aimax® -S Sensor Holder, All Ceramic Set; All-Purpose Esthetic Set; Carbide Burs; Bur Block;Crown Removal Set;Endodontic Access Set;, Apex Locator Systems, Artica Si, SureTact, Endo Motors and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Implant, Dental, Endosseous	NDP	1	Manufacturer	accessdata.fda.gov
Activator, Ultraviolet, For Polymerization	EBZ	2	Repackager or relabeler	accessdata.fda.gov
Bur, Dental	EJL	1	Manufacturer	accessdata.fda.gov
Chair, Dental, Without Operative Unit	NRU	1	Manufacturer	accessdata.fda.gov
Controller, Foot, Handpiece And Cord	EBW	1	Manufacturer	accessdata.fda.gov
Cup, Prophylaxis	EHK	1	Manufacturer	accessdata.fda.gov
Dam, Rubber	EIE	1	Repackager or relabeler	accessdata.fda.gov
Disk, Abrasive	EHJ	1	Manufacturer	accessdata.fda.gov
File, Pulp Canal, Endodontic	EKS	1	Manufacturer	accessdata.fda.gov
Film, Radiographic	IWZ	1	Manufacturer	accessdata.fda.gov
Forceps, Rubber Dam Clamp	EJG	1	Manufacturer	accessdata.fda.gov
Handle, Instrument, Dental	EJB	1	Manufacturer	accessdata.fda.gov
Handpiece, Air-Powered, Dental	EFB	1	Specification developer	accessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, Dental	EGS	1	Manufacturer, Specification developer	accessdata.fda.gov
Handpiece, Direct Drive, Ac-Powered	EKX	1	Repackager or relabeler	accessdata.fda.gov
Handpiece, Rotary Bone Cutting	KMW	2	Manufacturer	accessdata.fda.gov
Holder, Film, X-Ray	EGZ	1	Manufacturer	accessdata.fda.gov
Illuminator, Radiographic-Film	IXC	1	Manufacturer	accessdata.fda.gov
Instrument, Diamond, Dental	DZP	1	Manufacturer	accessdata.fda.gov
Instrument, Filling, Plastic, Dental	EIY	1	Manufacturer	accessdata.fda.gov
Intraoral Camera	QJK	2	Manufacturer	accessdata.fda.gov
Locator, Root Apex	LQY	U	Repackager or relabeler	accessdata.fda.gov
Retainer, Matrix	JEP	1	Manufacturer	accessdata.fda.gov
Scaler, Ultrasonic	ELC	2	Repackager or relabeler	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	Repackager or relabeler	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
September 22, 2023	K220179	High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors	EFB	Substantially Equivalent	Foshan Coxo Medical Instrument Co., Ltd.	accessdata.fda.gov
May 18, 2023	K220829	Endo Motor	EKX	Substantially Equivalent	Foshan Coxo Medical Instrument Co., Ltd.	accessdata.fda.gov
September 27, 2022	K220831	Dental Implantation Systems, Dental Electrical Motors	EBW	Substantially Equivalent	Foshan Coxo Medical Instrument Co., Ltd.	accessdata.fda.gov
July 20, 2022	K212178	Root Apex Locator	LQY	Substantially Equivalent	Foshan Coxo Medical Instrument Co., Ltd.	accessdata.fda.gov
October 7, 2021	K212279	Digital Intraoral X-ray Imaging System	MUH	Substantially Equivalent	Iray Technology Taicang , Ltd.	accessdata.fda.gov
December 2, 2011	K111907	DYNAMIC DU SERIES PORTABLE DENTAL UNIT	EIA	Substantially Equivalent	Shanghai Dynamic Industry Co., Ltd.	accessdata.fda.gov
March 19, 2008	K080025	LED.L, LED.M, LED.G, LED.B	EBZ	Substantially Equivalent	Guilin Woodpecker Medical Instrument Co., Ltd.	accessdata.fda.gov
August 21, 2006	K053555	ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L	ELC	Substantially Equivalent	Guilin Woodpecker Medical Instrument Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated September 22, 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.