Beyes Dental Canada Inc

Address:595 Middlefield Road, Unit 23,Toronto Ontario,CA

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Handpiece, Air-Powered, Dental (EFB) (5) Locator, Root Apex (LQY) (3) Controller, Foot, Handpiece And Cord (EBW) (1) Unit, Operative Dental, Accessories (NRD) (1)

Premarket Exempt

Yes No

Clear

AirLight M800 - 00628504370810 Catalog Number :

Device Description : M800-M/ST, STAR Backend, Triple Spray, Direct-LED

Device Class : 1

Duns Number: 244261462

Premarket Exempt : No

Product Code : EFB

Prescription Use : No

Device Count : 1

AirLight M800 - 00628504370827 Catalog Number :

Device Description : M800-M/M4, M4 Backend, Triple Spray, Direct-LED

Device Class : 1

Duns Number: 244261462

Premarket Exempt : No

Product Code : EFB

Prescription Use : No

Device Count : 1

DuraMax - 00628504370834 Catalog Number :

Device Description : M800-M/PD/NS PLUS Beyes PD Backend, Single Stream, Safeguard Air Technology, Direct-LED

Device Class : 1

Duns Number: 244261462

Premarket Exempt : No

Product Code : EFB

Prescription Use : No

Device Count : 1

DuraMax - 00628504370841 Catalog Number :

Device Description : M800-M/PD/NS,SMART,Beyes PD Backend, Single Stream, Safeguard Air Technology, Direct-LED

Device Class : 1

Duns Number: 244261462

Premarket Exempt : No

Product Code : EFB

Prescription Use : No

Device Count : 1

Canaview - 00837699000000 Catalog Number :

Device Description : Canaview Intra Oral Camera, Direct-USB, Auto-Focus

Device Class : 1

Duns Number: 244261462

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : Yes

Device Count : 1

MAXSO - 00837699000017 Catalog Number :

Device Description : Maxso E800P, Portable Electric Handpiece System

Device Class : 1

Duns Number: 244261462

Premarket Exempt : No

Product Code : EBW

Prescription Use : Yes

Device Count : 1

Airlight - 00837699000024 Catalog Number :

Device Description : M800-45/B2,45 Degree Head, Direct-LED, Triple Water Jet

Device Class : 1

Duns Number: 244261462

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

Accurator - 00837699000031 Catalog Number :

Device Description : Accurator A2, Apex Locator, compatible with G2 Endo Motor

Device Class : U

Duns Number: 244261462

Premarket Exempt : No

Product Code : LQY

Prescription Use : Yes

Device Count : 1

ApexPilot - 00837699000048 Catalog Number :

Device Description : ApexPilot G3,Endo Motor with Built-in Apex Locator

Device Class : U

Duns Number: 244261462

Premarket Exempt : No

Product Code : LQY

Prescription Use : Yes

Device Count : 1

ApexPilot - 00837699000055 Catalog Number :

Device Description : ApexPilot G2,Endo Motor, Connectable to Apex Locator

Device Class : U

Duns Number: 244261462

Premarket Exempt : No

Product Code : LQY

Prescription Use : Yes

Device Count : 1

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