Kube Innovation Inc

Address:540-5524 Saint-Patrick Street,Montreal Quebec,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

Dynamometer, Ac-Powered (LBB) (2)

Premarket Exempt

Yes

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Innobyte Clinical Package - D091INNOCA010 Catalog Number : INNOCA01

Device Description : The Innobyte is a measurement medical device for dental clinicians in the quanti The Innobyte is a measurement medical device for dental clinicians in the quantitative evaluations of a patient’s bite strength. Includes; 1 Innobyte Handpiece, 1 Mouthpiece Sensor, 100 Protective Sleeves, Wall-Mount USB charger, associated cables, Operations Manuals and Guides, & One Year Parts and Labor Warranty.

Device Class : 2

Duns Number: 201096437

Premarket Exempt : Yes

Product Code : LBB

Prescription Use : Yes

Device Count : 1

Innobyte Full-Arch Mouthpiece Sensor - D091INNOMP010 Catalog Number : INNOMP01

Device Description : The Innobyte Full-Arch Mouthpiece Sensor is a measurement medical device for den The Innobyte Full-Arch Mouthpiece Sensor is a measurement medical device for dental clinicians in the quantitative evaluations of a patient’s full arch bite strength. Must be used with Innobyte Handpiece and Protective Sleeves for proper functioning. Includes: 1 Mouthpiece, Operations Manuals and Guides, & One Year Parts and Labor Warranty.

Device Class : 2

Duns Number: 201096437

Premarket Exempt : Yes

Product Code : LBB

Prescription Use : No

Device Count : 1

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