TE-95 BC Turbine

GUDID J021300740000

Alegra High Speed Handpiece

W & H Dentalwerk Bürmoos GmbH

Dental surgical power tool motorized handpiece/set, pneumatic

• Primary Device ID: J021300740000
• NIH Device Record Key: 0abe3379-d0c5-4959-9e24-aff56276a89d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TE-95 BC Turbine
• Version Model Number: 30074000
• 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	J021300740000 [Direct Marking]
HIBCC	J021300740001 [Primary]

FDA Product Code

• EFB: Handpiece, Air-Powered, Dental

Sterilization

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

[J021300740000]

Moist Heat or Steam Sterilization

[J021300740000]

Moist Heat or Steam Sterilization

[J021300740000]

Moist Heat or Steam Sterilization

[J021300740000]

Moist Heat or Steam Sterilization

[J021300740000]

Moist Heat or Steam Sterilization

[J021300740000]

Moist Heat or Steam Sterilization

[J021300740000]

Moist Heat or Steam Sterilization

[J021300740000]

Moist Heat or Steam Sterilization

[J021300740000]

Moist Heat or Steam Sterilization

[J021300740000]

Moist Heat or Steam Sterilization

[J021300740000]

Moist Heat or Steam Sterilization

[J021300740000]

Moist Heat or Steam Sterilization

[J021300740000]

Moist Heat or Steam Sterilization

[J021300740000]

Moist Heat or Steam Sterilization

[J021300740000]

Moist Heat or Steam Sterilization

[J021300740000]

Moist Heat or Steam Sterilization

[J021300740000]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-06
• Device Publish Date: 2024-07-29

On-Brand Devices [TE-95 BC Turbine]

• J021100595090: Alegra Highspeed Handpiece
• J021300740000: Alegra High Speed Handpiece