Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008770655

FEI Number

3008770655

Entity Name

BEYES DENTAL INC

City/State/Country

Toronto Ontario, CA

Establishment Address

595 Middlefield Road, Unit 23, Toronto Ontario M1V 3S2, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Beyes Dental Inc (Owner Number: 10034597)

Owner / Operator Contact Address

595 Middlefield Road, Unit 23, Toronto, CA-ON M1V 3S2, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ultranate Impression Material; Beyes Impression Syringes AirLight Series Dental Handpieces DuraMax Extraoral Suction System - Aerosol Control, Models: X1, X2, X3, X4, X5, X6 X7 DURAY V2 X-Ray Unit Cotton Rolls MAXSO Series Dental Handpiece Electric Handpiece System: E600P; E800P; E800B; X99L Earloop Masks DURAY ART PLUS Pan/Ceph Beyes Dental Explorers Beyes Dental Chair Beyes Intraoral Scanner Beyes Comfort-Sonic Series Ultrasonic Scaler Slimax Series LED Curing Light Duray Intraoral Sensor, Model: DS1; DS2 Beyes Dental Bur Beyes Mouthpiece, Saliva Ejectors Beyes Probes Beyes Dental Anesthesia Device, H1; H2 Beyes Dental Mirror Beyes Dental Maxso Lowspeed handpiece Beyes Micro Applicators Beyes Dental Vacuum Pump CANAVIEW Intraoral Camera Caremaster Automatic Handpiece Lubrication System Beyes Oil-Less Air Compressors Handle Sleeves; Handpiece Sleeves; Light/Sensor Sleeves/Pouches; Tray Sleeves CORDLESS GUTTA PERCHA OBTURATION SYSTEM, P1;P2;P3;F1;F2;F3 Beyes MULTIPLE; Xray Viewer Paper Cups Dental Bibs Beyes Dental Light Beyes Dual-Secure Self-Seal Sterilization Pouches Duray Imaging Plate Scanner, Model:DC1 Beyes Gauze Beyes Universal Sensor Holder

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2011-02-05
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2012-02-08
EBR	Unit, Suction Operatory	Dental	Class 1	872.6640	2020-04-21
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2021-12-13
EFN	Cotton, Roll	Dental	Class 1	872.6050	2011-02-05
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2010-12-15
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2019-08-12
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2019-08-12
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-17
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2023-08-30
EKB	Explorer, Operative	Dental	Class 1	872.4565	2011-02-05
NRU	Chair, Dental, Without Operative Unit	Dental	Class 1	872.6250	2011-02-05
QJK	Intraoral Camera	Dental	Class 2	872.3661	2025-02-11
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2010-12-15
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2010-12-15
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2021-11-07
DZP	Instrument, Diamond, Dental	Dental	Class 1	872.4535	2021-07-23
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2010-12-14
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2011-02-05
EJI	Syringe, Cartridge	Dental	Class 2	872.6770	2023-08-30
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2011-02-05
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2017-04-05
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2017-04-05
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2011-02-05
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2011-02-05
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	2021-01-25
IXC	Illuminator, Radiographic-Film	Radiology	Class 1	892.1890	2011-02-05
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2011-02-05
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2011-02-05
EAZ	Light, Operating, Dental	Dental	Class 1	872.4630	2017-02-16
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2011-02-05
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2021-11-07
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2011-02-05
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2011-02-05

Official Correspondent

Jack Yang

US Agent Details

SEBASTIAN FEYE Business: Accurate Consultants Inc Email: sebastian@accuratefdaconsulting.com Phone: (619) 5170673

Related Public Records

Same Entity

Beyes Dental Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K212910	Shenzhen Carejoy Technology Co., Ltd.	Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece	2022-11-17
K991310	Villa Sistemi Medicali S.P.A.	EXPLOR-X 70	1999-06-18
K221008	Shanghai Handy Medical Equipment Co., Ltd.	HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)	2022-06-22
K160788	Ray Co., Ltd.	RIOScan (RPS500)	2016-04-15
K832443	California Technics, Inc.	ULTRASONIC DENTAL PROPHYLAXIS UNIT	1983-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2015	Gendex Corp	2	eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC Product Usage: intraoral x-ray
Z-0016-2017	Panoramic Rental Corp.	2	Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008770655. Last updated year: 2026. Please use registration number 3008770655 when referencing this establishment in official correspondence.