Innobyte Clinical Package

Primary DI
D091INNOCA010
Brand
Innobyte Clinical Package
Company
Kube Innovation Inc
Model
1.0
Catalog number
INNOCA01
Device description
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.
Published
2022-01-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LBBDynamometer, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBBDynamometer, Ac-PoweredOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D091INNOCA010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dynamometer attachmentA non-powered component of a dynamometer designed to be attached to the force gauge of the dynamometer to allow the patient to apply force to the gauge in the desired manner during use (i.e., assessment of neuromuscular function). It may be available in a variety of forms (e.g., cable, grip bar, wall pad, adaptor); it is not intended for pain testing. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
15144003713info@kubeinnovation.com

Regulatory Flags#

DUNS number
201096437
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D091INNOCP030Innobyte Bilateral Clinical Package1.0INNOCP032023-06-26
D091INNOMP030Innobyte Bilateral Mouthpiece Replacement1.0INNOMP032023-06-26
D091INNOMP010Innobyte Full-Arch Mouthpiece Sensor1.0INNOMP012022-01-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809513720298SAEHAN Digital Hand Dynamometer(DHD-1)Saehan CorporationLBB2026-05-18
08809513720373SAEHAN Digital Hand Dynamometer(DHD-3)Saehan CorporationLBB2026-05-18
00850004866184ActivForce 2ActivBody, Inc.LBB2025-09-03
05430004547006EfortoUniwebLBB2025-03-07
00850002429114microfet handgripHoggan Scientific L.L.C.LBB2025-02-25
00850002429190microFET PinchHoggan Scientific L.L.C.LBB2025-02-25
00850002429312microfet3Hoggan Scientific L.L.C.LBB2025-02-24
00850002429008microfet2Hoggan Scientific L.L.C.LBB2025-02-21
03770011995370KForce Muscle ControllerKINVENT BIOMECANIQUELBB2024-01-03
03770011995424KForce LinkKINVENT BIOMECANIQUELBB2024-01-03
03770011995431KForce GripKINVENT BIOMECANIQUELBB2024-01-03
03770011995455KForce BubbleKINVENT BIOMECANIQUELBB2024-01-03
D091INNOCP030Innobyte Bilateral Clinical PackageKube Innovation IncLBB2023-06-26
D091INNOMP030Innobyte Bilateral Mouthpiece ReplacementKube Innovation IncLBB2023-06-26
D091INNOMP010Innobyte Full-Arch Mouthpiece SensorKube Innovation IncLBB2022-01-11
03770011995004KINVENTKINVENT HELLASLBB2020-08-01
03770011995103KINVENTKINVENT HELLASLBB2020-08-01
03770011995332KINVENTKINVENT HELLASLBB2020-08-01
03770011995448KINVENTKINVENT HELLASLBB2020-08-01
B824SR3053M1SR-3053RED OAK INSTRUMENTS, LLCLBB2020-01-10
B824SR3053S1SR-3053RED OAK INSTRUMENTS, LLCLBB2020-01-10
10850828007012AcroGrip™ DeviceAXOGEN CORPORATIONLBB2017-05-15
10850828007029AcroPinch™ DeviceAXOGEN CORPORATIONLBB2017-05-15