Data / Medical devices / Canada / Beyes Dental Inc

Beyes Dental Inc: FDA-registered device maker in Toronto Ontario, Canada, 16 510(k) clearances

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

Beyes Dental Inc is registered with the FDA (registration 3008770655) in Toronto Ontario, Canada. It lists 43 device types. The FDA files 16 510(k) clearances under its listings, the newest dated February 7, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3008770655
Address: 595 Middlefield Road, Unit 23, Toronto Ontario, Canada, M1V 3S2
Owner or operator: Beyes Dental Inc (10034597)
Roles: Manufacturer
First device listed: December 14, 2010
Registered through: 2026
Brand names listed: AirLight Series Dental Handpieces, Beyes Accurator Apex Locator, A1;A2;A3;A4;A5, Beyes Comfort-Sonic Series Ultrasonic Scaler, Beyes Curettes, Beyes Dental Anesthesia Device, H1; H2, Beyes Dental Bur, Beyes Dental Chair, Beyes Dental Chair With Operative Unit and more

Devices it lists

Device	Product code	Class	Role	Source
Absorber, Saliva, Paper	KHR	1	Manufacturer	accessdata.fda.gov
Accessory, Surgical Apparel	LYU	1	Manufacturer	accessdata.fda.gov
Activator, Ultraviolet, For Polymerization	EBZ	2	Manufacturer	accessdata.fda.gov
Applicator, Absorbent Tipped, Non-Sterile	KXF	1	Manufacturer	accessdata.fda.gov
Bur, Dental	EJL	1	Manufacturer	accessdata.fda.gov
Chair, Dental, With Operative Unit	KLC	1	Manufacturer	accessdata.fda.gov
Chair, Dental, Without Operative Unit	NRU	1	Manufacturer	accessdata.fda.gov
Cotton, Roll	EFN	1	Manufacturer	accessdata.fda.gov
Cup, Prophylaxis	EHK	1	Manufacturer	accessdata.fda.gov
Curette, Endodontic	EKT	1	Manufacturer	accessdata.fda.gov
Dam, Rubber	EIE	1	Manufacturer	accessdata.fda.gov
Dispenser, Liquid Medication	KYX	1	Manufacturer	accessdata.fda.gov
Explorer, Operative	EKB	1	Manufacturer	accessdata.fda.gov
File, Pulp Canal, Endodontic	EKS	1	Manufacturer	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Manufacturer	accessdata.fda.gov
Gutta-Percha	EKM	1	Manufacturer	accessdata.fda.gov
Handpiece, Air-Powered, Dental	EFB	1	Manufacturer	accessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, Dental	EGS	1	Manufacturer	accessdata.fda.gov
Handpiece, Direct Drive, Ac-Powered	EKX	1	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
Intraoral Camera	QJK	2	Manufacturer	accessdata.fda.gov
Light, Operating, Dental	EAZ	1	Manufacturer	accessdata.fda.gov
Locator, Root Apex	LQY	U	Manufacturer	accessdata.fda.gov
Mask, Surgical	FXX	2	Manufacturer	accessdata.fda.gov
Mirror, Mouth	EAX	1	Manufacturer	accessdata.fda.gov
Mouthpiece, Saliva Ejector	DYN	1	Manufacturer	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Manufacturer	accessdata.fda.gov
Plugger, Root Canal, Endodontic	EKR	1	Manufacturer	accessdata.fda.gov
Point, Paper, Endodontic	EKN	1	Manufacturer	accessdata.fda.gov
Probe, Periodontic	EIX	1	Manufacturer	accessdata.fda.gov
Scaler, Periodontic	EMN	1	Manufacturer	accessdata.fda.gov
Scaler, Ultrasonic	ELC	2	Manufacturer	accessdata.fda.gov
Syringe, Cartridge	EJI	2	Manufacturer	accessdata.fda.gov
Syringe, Restorative And Impression Material	EID	1	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, Operative Dental, Accessories	NRD	1	Manufacturer	accessdata.fda.gov
Unit, Suction Operatory	EBR	1	Manufacturer	accessdata.fda.gov
Unit, X-Ray, Extraoral With Timer	EHD	2	Manufacturer	accessdata.fda.gov
Wrap, Sterilization	FRG	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
February 7, 2025	K242404	BDC Dental Unit	EIA	Substantially Equivalent	Bdc Dental Corporation , Ltd.	accessdata.fda.gov
March 2, 2022	K213579	Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph	OAS	Substantially Equivalent	Fona S.R.L	accessdata.fda.gov
October 7, 2021	K212279	Digital Intraoral X-ray Imaging System	MUH	Substantially Equivalent	Iray Technology Taicang , Ltd.	accessdata.fda.gov
September 27, 2021	K212080	Imaging Plate Scanner, i-Scan	MUH	Substantially Equivalent	Guilin Woodpecker Medical Instrument Co., Ltd.	accessdata.fda.gov
March 5, 2021	K203425	Surgical Mask	FXX	Substantially Equivalent	Bdc Dental Corporation , Ltd.	accessdata.fda.gov
June 30, 2020	K191276	Dental Electrical Motor iRoot Pro	EKX	Substantially Equivalent	Changzhou Bomedent Medical Technology Co.,Ltd	accessdata.fda.gov
December 18, 2018	K181087	Apex Locator, DPEX III	LQY	Substantially Equivalent	Guilin Woodpecker Medical Instrument Co., Ltd.	accessdata.fda.gov
November 3, 2016	K161131	FONA Pan/Ceph	MUH	Substantially Equivalent	Fona S.R.L	accessdata.fda.gov
April 24, 2015	K150798	Codent Low Speed Dental Handpieces and Accessories	EFB	Substantially Equivalent	Codent Technical Industry Co., Ltd.	accessdata.fda.gov
October 24, 2014	K133069	CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES	EFB	Substantially Equivalent	Codent Technical Industry Co., Ltd.	accessdata.fda.gov
December 16, 2011	K112623	AIRLIGHT DENTAL HANDPIECE	EFB	Substantially Equivalent	Beyes Dental Canada, Inc.	accessdata.fda.gov
September 9, 2010	K101551	PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M	EFB	Substantially Equivalent	Delma Medical Instrument (Guangzhou) 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
December 27, 2007	K071886	SELF SEAL STERILIZATION POUCH	FRG	Substantially Equivalent	Shanghai Jianzhong Medical Packaging 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
July 8, 2003	K031118	INTRAOS 70	EHD	Substantially Equivalent	Blue X Imaging Srl	accessdata.fda.gov

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Updated February 7, 2025. 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.