XDR CLARITY

Basic Information

• Brand Name: XDR CLARITY
• Primary DI: D787XDR4P10ACSZ10
• Version / Model: XDR4P10SZ1
• Company Name: CYBER MEDICAL IMAGING, INC.
• Labeler DUNS: 112029934
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-08
• Public Version: 1
• Public Version Date: 2023-05-16
• Public Version Status: New
• Public Device Record Key: 54e7cef5-4f8e-4e3c-8b6a-2ea428aea289

Device Description

XDR CLARITY - Size-1 Digital Intraoral Sensor

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: No
• 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: Yes
• Sterilization Methods: Liquid Chemical

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	D787XDR4P10ACSZ10	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K013271	000

Device Sizes

Type	Value	Unit	Text
Length	36.2	Millimeter
Width	24.2	Millimeter
Height	5.5	Millimeter

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: SAME AS HANDLING CONDITIONS