Proxeo ULTRA PB-530

Basic Information

• Brand Name: Proxeo ULTRA PB-530
• Primary DI: J021303250001
• Version / Model: 30325000
• Company Name: W & H Dentalwerk Bürmoos GmbH
• Labeler DUNS: 300238441
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-19
• Public Version: 1
• Public Version Date: 2023-07-27
• Public Version Status: New
• Public Device Record Key: 64c8c268-8aa7-4887-97c3-b77738379492

Device Description

Ultrasonic scaler drive unit

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
ELC	Scaler, Ultrasonic	Dental	872.4850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47013	Dental ultrasonic surgical system generator	A mains electricity (AC-powered) component of a dental ultrasonic surgical system used to generate a high frequency electrical current that is converted, typically within a handpiece, into an ultrasonic oscillation to mechanically fragment and cut bone upon contact with a vibrating tip during dental surgery, typically in combination with irrigation. It provides the controls and monitoring functions for the system during the procedure, and typically regulates energy to the system via a foot-switch.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	J021303250000	HIBCC
Primary	J021303250001	HIBCC