KaVo IXS Size 1 Sensor

Basic Information

• Brand Name: KaVo IXS Size 1 Sensor
• Primary DI: D090101329140
• Version / Model: 1.013.2914
• Catalog Number: 10132914
• Company Name: Dental Imaging Technologies Corporation
• Labeler DUNS: 800111106
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-04
• Public Version: 2
• Public Version Date: 2022-08-30
• Public Version Status: Update
• Public Device Record Key: f9d93264-56ca-40a0-b196-a76c68af69f6

Device Description

This is a kit containing a medical device.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MUH	System, x-ray, extraoral source, digital	Dental	872.1800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44905	Dental digital imaging sensor, intraoral	An analogue device that is temporarily placed in a patient's mouth to perform routine diagnostic dental imaging procedures. It uses analogue-to-digital conversion techniques to record the absorption pattern of x-ray beams used in the diagnosis and treatment of diseases of the jaw or oral cavity structures. The device is used in combination with the x-ray source (x-ray tube) that is located outside the patient's mouth during the imaging procedure; the resulting digital image is transmitted to a monitor or workstation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D090101329140	HIBCC
Previous	EKAV101329140	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius