Proxeo ULTRA PB-530

GUDID J021303250000

Ultrasonic scaler drive unit

W & H Dentalwerk Bürmoos GmbH

Dental ultrasonic surgical system generator

• Primary Device ID: J021303250000
• NIH Device Record Key: 64c8c268-8aa7-4887-97c3-b77738379492
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Proxeo ULTRA PB-530
• Version Model Number: 30325000
• Company DUNS: 300238441
• Company Name: W & H Dentalwerk Bürmoos GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J021303250000 [Direct Marking]
HIBCC	J021303250001 [Primary]

FDA Product Code

• ELC: Scaler, Ultrasonic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-27
• Device Publish Date: 2023-07-19

Devices Manufactured by W & H Dentalwerk Bürmoos GmbH

• J021302100000 - SI-SQ: 2024-09-19 Osstell Module
• J021100355000 - ZA-55 L Scaler: 2024-08-08 Air Scaler with light
• J021100355010 - ZA-55 Scaler: 2024-08-08 ZA-55 Scaler without light
• J021100355020 - ZA-55 LM Air Scaler: 2024-08-08 Air Scaler with light
• J021100355030 - ZA-55 M Scaler without light: 2024-08-08 Air Scaler without light
• J021100355110 - SF1LM KO Air Scaler: 2024-08-08 Brasseler Air Scaler
• J021100355120 - SF1LM A1 Air Scaler: 2024-08-08 Air Scaler Brasseler
• J021100355311 - ZA-55 Synea Scaler: 2024-08-08