CLAROX

Basic Information

• Brand Name: CLAROX
• Primary DI: 08800124900000
• Version / Model: VX-30
• Catalog Number: VX-30
• Company Name: VSI Co., Ltd.
• Labeler DUNS: 690151865
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-25
• Public Version: 1
• Public Version Date: 2022-08-02
• Public Version Status: New
• Public Device Record Key: b5d986c9-cd8e-475d-b926-23150e224915

Device Description

CLAROX is a battery-operated, portable dental X-ray source designed for handheld operation. It is designed to produce diagnostic quality X-ray images. The CLAROX is designed for use in a dental office. It can also be used in other similar environments (orthodontic office, general practitioner’s office, hospital ward, etc.) where appropriate safeguards are implemented. The device uses a rechargeable battery to allow for the use of the CLAROX where transportation or use of other x-ray devices might be prohibitive due to the other device’s size and/or lack of mobility. The CLAROX is an X-ray device with an AC/DC adaptor. The handheld device features a main body (tube head), Cone for sensor, Acryl shielding, cradle, and AC/DC adaptor.

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
44606	Hand-held intraoral dental x-ray system, digital	A diagnostic dental x-ray system designed 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. It is designed to be easily carried from location to location by a single operator. The sensor is placed in the mouth, the purpose being to visualize a limited region in detail. The data is either from analogue imaging and digitized afterwards or by digital imaging.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	18800124900007	GS1	Cardboard box	5	In Commercial Distribution
Primary	08800124900000	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K221286	000

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 80 – 106 KiloPascal
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 80 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 5 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 5 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 15 – 40 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius