Manufacturer registered with FDA
Onvet Medical Canada Inc.
TORONTO, Canada. Lists 24 dental device types with FDA across 1 registered establishment.
- Device types listed
- 24
- Brands and models
- 27
- 510(k) clearances
- 0as applicant
- Markets registered in
- 227 registrations outside the US
- Establishments
- 1Canada
Registered in 2 markets
Where regulators' registries name Onvet Medical Canada Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Onvet Medical Canada Inc. | 24 device types | — | Below |
| Canada | Health Canada | Registration holder | ONVET MEDICAL CANADA INC. | 27 | 2023–2026 | Pure 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 Onvet Medical Canada Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Maker | AMW AirPeak G100, G200, G200X;G300, G400,MT05;MT20; P100; AMW iTesla G500, G600, G700, G800,MT40iTesla Dental Implant System | 2023 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | Markson SureFita | 2023 |
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Maker | iTesla Dental Implant System | 2024 |
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Lister | ModuLite LED Curing Light System | 2023 |
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | AMW AirPeak G100, G200, G200X;G300, G400,MT05;MT20; P100; AMW iTesla G500, G600, G700, G800,MT40 | 2023 |
| X-Ray Film HolderEGZ · Class 1 | — | Maker | Aimax®-F Flim Holder; Aimax® -S Sensor Holder | 2024 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Maker | SurePoli Polishing Disc System, SureFita IPR system | 2023 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | Glacier® Angles and Cups | 2024 |
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Lister | Mobilio Portable Dental Unit. | 2024 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Lister | Markson Flowdam | 2023 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | Artica Si, SureTact | 2023 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | SureTact G3 Wedge; SureTact Classico Wedge; SureTact Woodwedge; | 2023 |
| Rubber Dam Clamp ForcepsEJG · Class 1 | Rubber dam systems | Maker | SureTact G3, G4, G5,G6,G8® | 2023 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | All Ceramic Set; All-Purpose Esthetic Set; Carbide Burs; Bur Block;Crown Removal Set;Endodontic Access Set;Fiber Post Drill;IPR Set; Crown & Bridge set; Inlay/Onlay Set; Root Shaping Set; Finishing Set; Soft Tissue Trimmer;Post Drills; Posterior Composite Set; Resin Sculpting Set;T&F Carbides; SoloGood | 2024 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | Hedstrom Files; K-Files; T-ONE Platinum; GlidePath; Twisted Files;Adaptive Files;Non-Sterile Files | 2024 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Lister | Endo Motors | 2024 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Lister | AMW-Stronic Series Ultrasonic Scaler | 2023 |
| Matrix RetainerJEP · Class 1 | Dental hand instruments | Maker | SureTact G3 Matrix; SureTact Classic Matrix; SureTact G6 Matrix;SureTact G8 Matrix;SureTact G9 Matrix;SureTact G7 Matrix | 2023 |
| Rotary Bone Cutting HandpieceKMW · Class 2 | Surgical drills & motors | Maker | iTesla Dental Implant System | 2024 |
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | Intraoral Sensor, Size 1, Size 2 | 2024 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | iTesla Eletric Implant Torque Wrench | 2024 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | iSuni, Intraoral Scanner, 3D, IOS, oScan, Model 1, Model 2, Model 3, Model 5, Model 6, Model 7, Model 8, Model 9, | 2024 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | Mobilio Dental Chair | 2024 |
| Intraoral CameraQJK · Class 2 | Intraoral cameras | Maker | Intraoral Camera C1, C2,C3,C4,C5,C6,C7,C8,C9 | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Onvet Medical Canada Inc. 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: Foshan COXO Medical Instrument Co., Ltd. (3), Guilin Woodpecker Medical Instrument Co., Ltd. (2), Iray Technology Taicang , Ltd. (1), Shanghai Dynamic Industry Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 22 Sep 2023 | K220179 | High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors | Foshan COXO Medical Instrument Co., Ltd. | EFB Dental Air-Powered Handpiece |
| 18 May 2023 | K220829 | Endo Motor | Foshan COXO Medical Instrument Co., Ltd. | EKX Ac-Powered Direct Drive Handpiece |
| 27 Sep 2022 | K220831 | Dental Implantation Systems, Dental Electrical Motors | Foshan COXO Medical Instrument Co., Ltd. | EBW Handpiece and Cord Foot Controller |
| 7 Oct 2021 | K212279 | Digital Intraoral X-ray Imaging System | Iray Technology Taicang , Ltd. | MUH Digital Extraoral Source X-Ray System |
| 2 Dec 2011 | K111907 | DYNAMIC DU SERIES PORTABLE DENTAL UNIT | Shanghai Dynamic Industry Co., Ltd. | EIA Operative Dental Unit |
| 19 Mar 2008 | K080025 | LED.L, LED.M, LED.G, LED.B | Guilin Woodpecker Medical Instrument Co., Ltd. | EBZ Ultraviolet Activator for Polymerization |
| 21 Aug 2006 | K053555 | ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L | Guilin Woodpecker Medical Instrument Co., Ltd. | ELC Ultrasonic Scaler |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ONVET MEDICAL CANADA INCFDA reg. 3030126955 | TORONTO Ontario, Canada | Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10089540). 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.