APP-HC-03-XX-00 (Head Controller)

GUDID J021303440001

Built-in Component

W & H Dentalwerk Bürmoos GmbH

Dental delivery system instrument unit, electric

• Primary Device ID: J021303440001
• NIH Device Record Key: 4ce10f84-9e71-4693-bbc8-2534f1dd56fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APP-HC-03-XX-00 (Head Controller)
• Version Model Number: 30344000
• 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	J021303440000 [Direct Marking]
HIBCC	J021303440001 [Primary]

FDA Product Code

• EIA: Unit, Operative Dental

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

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• 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