PROX

Basic Information

• Brand Name: PROX
• Primary DI: 08800021800007
• Version / Model: 1
• Catalog Number: DPC-04
• Company Name: DigiMed Co., Ltd.
• Labeler DUNS: 688265810
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-07
• Public Version: 3
• Public Version Date: 2023-12-25
• Public Version Status: Update
• Public Device Record Key: 10d66177-1945-4841-a4c5-049f85c06df6

Device Description

The PROX is a hand-held diagnostic dental x-ray system. It is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source producing diagnostic X-ray images using with intra-oral image receptors. Its use is intended for adults and pediatric subjects both. This device includes a high frequency inverter that changes direct current to alternating current, X-ray tube, electrical protective devices, and other elements. The system helps to get sharp and clear x-ray images, and its low radiation dosage keeps patients and dentists safe from leakage radiation.

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	78800021800006	GS1	Carton Package	8	In Commercial Distribution
Primary	08800021800007	GS1
Package	68800021800009	GS1	Carton Package	7	In Commercial Distribution
Package	58800021800002	GS1	Carton Package	6	In Commercial Distribution
Package	88800021800003	GS1	Carton Package	5	In Commercial Distribution
Package	48800021800005	GS1	Carton Package	4	In Commercial Distribution
Package	38800021800008	GS1	Carton Package	3	In Commercial Distribution
Package	28800021800001	GS1	Carton Package	2	In Commercial Distribution
Package	18800021800004	GS1	Carton Package	1	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K082167	000

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 80 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 10 – 85 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 80 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 5 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius