FDA.reportPublic FDA data

Innobyte Bilateral Clinical Package

Primary DI
D091INNOCP030
Brand
Innobyte Bilateral Clinical Package
Company
Kube Innovation Inc
Model
1.0
Catalog number
INNOCP03
Device description
The Innobyte is a 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
2023-06-26
Public version status
Update
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
D091INNOCP030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Gnathodynamometer mouthpiece coverA disposable device intended to cover a gnathodynamometer mouthpiece while in use to provide a hygienic barrier. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-511-8792info@kubeinnovation.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D091INNOMP030Innobyte Bilateral Mouthpiece Replacement1.0INNOMP032023-06-26
D091INNOMP010Innobyte Full-Arch Mouthpiece Sensor1.0INNOMP012022-01-11
D091INNOCA010Innobyte Clinical Package1.0INNOCA012022-01-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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
D091INNOMP030Innobyte Bilateral Mouthpiece ReplacementKube Innovation IncLBB2023-06-26
D091INNOCA010Innobyte Clinical PackageKube Innovation IncLBB2022-01-11
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