FDA.reportPublic FDA data

Innobyte Bilateral Mouthpiece Replacement

Primary DI
D091INNOMP030
Brand
Innobyte Bilateral Mouthpiece Replacement
Company
Kube Innovation Inc
Model
1.0
Catalog number
INNOMP03
Device description
The Innobyte Bilateral 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.
Published
2023-06-26
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
D091INNOMP030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Gnathodynamometer mouthpieceA mouthpiece intended to be attached to a gnathodynamometer control unit (not included) to measure maximal bite force. It is typically filled with a fluid medium which transmits the measured force to sensors in the control unit when force is applied by closing the jaw/mouth. This is a reusable 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
D091INNOCP030Innobyte Bilateral Clinical Package1.0INNOCP032023-06-26
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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03770011995431KForce GripKINVENT BIOMECANIQUELBB2024-01-03
03770011995455KForce BubbleKINVENT BIOMECANIQUELBB2024-01-03
D091INNOCP030Innobyte Bilateral Clinical PackageKube 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