Innobyte Bilateral Clinical Package INNOCP03

GUDID D091INNOCP030

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.

Kube Innovation Inc

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Primary Device IDD091INNOCP030
NIH Device Record Key42a26543-e182-492e-b465-50e211baf987
Commercial Distribution StatusIn Commercial Distribution
Brand NameInnobyte Bilateral Clinical Package
Version Model Number1.0
Catalog NumberINNOCP03
Company DUNS201096437
Company NameKube Innovation Inc
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-511-8792
Emailinfo@kubeinnovation.com
Phone1-800-511-8792
Emailinfo@kubeinnovation.com
Phone1-800-511-8792
Emailinfo@kubeinnovation.com
Phone1-800-511-8792
Emailinfo@kubeinnovation.com
Phone1-800-511-8792
Emailinfo@kubeinnovation.com
Phone1-800-511-8792
Emailinfo@kubeinnovation.com
Phone1-800-511-8792
Emailinfo@kubeinnovation.com
Phone1-800-511-8792
Emailinfo@kubeinnovation.com
Phone1-800-511-8792
Emailinfo@kubeinnovation.com
Phone1-800-511-8792
Emailinfo@kubeinnovation.com
Phone1-800-511-8792
Emailinfo@kubeinnovation.com
Phone1-800-511-8792
Emailinfo@kubeinnovation.com
Phone1-800-511-8792
Emailinfo@kubeinnovation.com
Phone1-800-511-8792
Emailinfo@kubeinnovation.com
Phone1-800-511-8792
Emailinfo@kubeinnovation.com
Phone1-800-511-8792
Emailinfo@kubeinnovation.com
Phone1-800-511-8792
Emailinfo@kubeinnovation.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD091INNOCP030 [Primary]

FDA Product Code

LBBDynamometer, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-04
Device Publish Date2023-06-26

Devices Manufactured by Kube Innovation Inc

D091INNOCP030 - Innobyte Bilateral Clinical Package2023-07-04The 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.
D091INNOCP030 - Innobyte Bilateral Clinical Package2023-07-04 The Innobyte is a medical device for dental clinicians in the quantitative evaluations of a patient’s bite strength. Includes;
D091INNOMP030 - Innobyte Bilateral Mouthpiece Replacement2023-07-04 The Innobyte Bilateral Mouthpiece Sensor is a measurement medical device for dental clinicians in the quantitative evaluations o
D091INNOCA010 - Innobyte Clinical Package2022-01-19 The Innobyte is a measurement medical device for dental clinicians in the quantitative evaluations of a patient’s bite strengt
D091INNOMP010 - Innobyte Full-Arch Mouthpiece Sensor2022-01-19 The Innobyte Full-Arch Mouthpiece Sensor is a measurement medical device for dental clinicians in the quantitative evaluations o

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