Manufacturer registered with FDA
Beyes Dental Inc
Toronto, Canada. Lists 34 dental device types with FDA across 1 registered establishment.
- Device types listed
- 34
- Brands and models
- 48
- 510(k) clearances
- 0as applicant
- Markets registered in
- 598 registrations outside the US
- Establishments
- 1Canada
Registered in 5 markets
Where regulators' registries name Beyes Dental Inc as the manufacturer or the registration holder of a device.
RegisteredHome: CanadaOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Beyes Dental Inc | 34 device types | — | Below |
| Canada | Health Canada | Registration holder | BEYES DENTAL INC. | 65 | 2011–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Beyes Dental Inc | 25 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Beyes Dental Inc. | 6 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Beyes Dental Inc | 2 | 2026–2026 | 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 Beyes Dental 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 Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | AirLight Series Dental HandpiecesBeyes Dental Maxso Lowspeed handpieceElectric Handpiece System: E600P; E800P; E800B; X99LMAXSO Series Dental Handpiece | 2010 |
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | DURAY ART PLUS Pan/CephDuray Imaging Plate Scanner, Model:DC1Duray Intraoral Sensor, Model: DS1; DS2 | 2021 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Maker | Beyes Dental Maxso Lowspeed handpieceElectric Handpiece System: E600P; E800P; E800B; X99L | 2017 |
| Saliva Ejector MouthpieceDYN · Class 1 | — | Maker | Beyes Mouthpiece, Saliva Ejectors | 2010 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | Beyes Dental Bur | 2021 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Beyes Dental Mirror | 2011 |
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Maker | Beyes Dental Light | 2017 |
| Suction Operatory UnitEBR · Class 1 | Suction & evacuation units | Maker | DuraMax Extraoral Suction System - Aerosol Control, Models: X1, X2, X3, X4, X5, X6 X7 | 2020 |
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Maker | Slimax Series LED Curing Light | 2010 |
| Roll CottonEFN · Class 1 | — | Maker | Cotton Rolls | 2011 |
| X-Ray Film HolderEGZ · Class 1 | — | Maker | Beyes Universal Sensor Holder | 2011 |
| Extraoral with Timer X-Ray UnitEHD · Class 2 | Dental X-ray units | Maker | DURAY V2 X-Ray Unit | 2021 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | easyProphy Disposable Angles and Cups | 2011 |
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | Beyes Dental Chair With Operative UnitComfortek Mobile Dental SystemComfortek Portable Dental System | 2025 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | Ultranate Impression Material; Beyes Impression Syringes | 2011 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | Dental Rubber Dams | 2011 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Maker | Beyes Probes | 2011 |
| Cartridge SyringeEJI · Class 2 | Dental needles & syringes | Maker | Beyes Dental Anesthesia Device, H1; H2 | 2023 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Beyes Dental Bur | 2021 |
| Operative ExplorerEKB · Class 1 | Dental hand instruments | Maker | Beyes Dental Explorers | 2011 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | Curvea Gutta Percha; Curvea ONE Gutta Percha; Curvea CM Preserve Gutta Percha | 2026 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | Curvea Paper Points; Curvea ONE Paper Points; Curvea CM Preserve Paper Points | 2026 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | CORDLESS GUTTA PERCHA OBTURATION SYSTEM, P1;P2;P3;F1;F2;F3 | 2021 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | Curvea Endodontics Files; Curvea ONE Endodontics Files; Curvea CM Preserve Endodontics Files | 2026 |
| Endodontic CuretteEKT · Class 1 | Dental hand instruments | Maker | Beyes Curettes | 2011 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Maker | Endo motor, G1;G2;G3;G4;G5 | 2021 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Maker | Beyes Comfort-Sonic Series Ultrasonic Scaler | 2010 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | Beyes Scalers | 2011 |
| Paper Saliva AbsorberKHR · Class 1 | — | Maker | Dental Bibs | 2011 |
| Dental Chair with Operative UnitKLC · Class 1 | Dental chairs & operative units | Maker | Beyes Dental Chair With Operative UnitComfortek Mobile Dental SystemComfortek Portable Dental System | 2025 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | Beyes Dental Vacuum PumpBeyes Oil-Less Air CompressorsCANAVIEW Intraoral CameraCaremaster Automatic Handpiece Lubrication SystemHandle Sleeves; Handpiece Sleeves; Light/Sensor Sleeves/Pouches; Tray Sleeves | 2011 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | Beyes Dental Chair | 2011 |
| Dental Computed Tomography X-RayOAS · Class 2 | Dental CBCT | Maker | DURAY 2D, DURAY 2D Ceph, DURAY 3D and DURAY 3D Ceph | 2023 |
| Intraoral CameraQJK · Class 2 | Intraoral cameras | Maker | Beyes Intraoral Scanner | 2025 |
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
Beyes Dental 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: Guilin Woodpecker Medical Instrument Co., Ltd. (3), Fona S.R.L (2), Codent Technical Industry Co., Ltd. (2), Bdc Dental Corporation , Ltd. (1), Iray Technology Taicang , Ltd. (1), ChangZhou BoMedent Medical Technology Co., Ltd (1), Beyes Dental Canada, Inc. (1), Delma Medical Instrument (Guangzhou) Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 7 Feb 2025 | K242404 | BDC Dental Unit | Bdc Dental Corporation , Ltd. | EIA Operative Dental Unit |
| 2 Mar 2022 | K213579 | Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph | Fona S.R.L | OAS Dental Computed Tomography X-Ray |
| 7 Oct 2021 | K212279 | Digital Intraoral X-ray Imaging System | Iray Technology Taicang , Ltd. | MUH Digital Extraoral Source X-Ray System |
| 27 Sep 2021 | K212080 | Imaging Plate Scanner, i-Scan | Guilin Woodpecker Medical Instrument Co., Ltd. | MUH Digital Extraoral Source X-Ray System |
| 30 Jun 2020 | K191276 | Dental Electrical Motor iRoot Pro | ChangZhou BoMedent Medical Technology Co., Ltd | EKX Ac-Powered Direct Drive Handpiece |
| 3 Nov 2016 | K161131 | FONA Pan/Ceph | Fona S.R.L | MUH Digital Extraoral Source X-Ray System |
| 24 Apr 2015 | K150798 | Codent Low Speed Dental Handpieces and Accessories | Codent Technical Industry Co., Ltd. | EFB Dental Air-Powered Handpiece |
| 24 Oct 2014 | K133069 | CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES | Codent Technical Industry Co., Ltd. | EFB Dental Air-Powered Handpiece |
| 16 Dec 2011 | K112623 | AIRLIGHT DENTAL HANDPIECE | Beyes Dental Canada, Inc. | EFB Dental Air-Powered Handpiece |
| 9 Sep 2010 | K101551 | PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M | Delma Medical Instrument (Guangzhou) Co., Ltd. | EFB Dental Air-Powered Handpiece |
| 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 |
| 8 Jul 2003 | K031118 | INTRAOS 70 | Blue X Imaging Srl | EHD Extraoral with Timer X-Ray Unit |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| BEYES DENTAL INCFDA reg. 3008770655 | Toronto Ontario, Canada | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10034597). 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.