X-MIND unity

Basic Information

• Brand Name: X-MIND unity
• Primary DI: D804W08000160
• Version / Model: XMU BOTTOM 80 LONG SQUARE CON
• Catalog Number: W0800016
• Company Name: DE GÖTZEN SRL
• Labeler DUNS: 433051802
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 5
• Public Version Date: 2023-04-25
• Public Version Status: Update
• Public Device Record Key: 213f4d9d-8fb4-4144-884d-bb977f03ce4e

Device Description

The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, the X-MIND unity is an extra-oral source of X-rays, intended to be used for producing diagnostic dental radiographs for treatment of disease of the teeth, jaw and oral structures.

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: Yes
• 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
EHD	Unit, X-Ray, Extraoral With Timer	Dental	872.1800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42297	Stationary intraoral dental x-ray system, digital	A diagnostic dental x-ray system designed for permanent fixture in one location to generate and control x-ray beams. It records the absorption pattern of x-ray beams used for general-purpose, routine, dental radiography examinations involving the diagnosis and treatment (e.g., surgical or interventional) of diseases of the teeth, jaw and oral cavity structures. The sensor is placed in the mouth, the purpose being to visualize a limited region in detail. The data is either from analogue-to-digital conversion techniques imaging or by digital imaging.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D804W08000160	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K132378	000

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 85 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 25 – 75 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 85 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 25 – 75 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 0 – 50 Degrees Celsius