WG-67 A

GUDID J021300850000

Synea Fusion (Profin) Handpiece

W & H Dentalwerk Bürmoos GmbH

Dental surgical power tool motorized handpiece/set, electric

• Primary Device ID: J021300850000
• NIH Device Record Key: 0cd2a895-aea6-452a-829d-2a887be9171b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WG-67 A
• Version Model Number: 30085000
• 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	J021300850000 [Direct Marking]
HIBCC	J021300850001 [Primary]

FDA Product Code

• EFB: Handpiece, Air-Powered, Dental

Sterilization

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

[J021300850000]

Moist Heat or Steam Sterilization

[J021300850000]

Moist Heat or Steam Sterilization

[J021300850000]

Moist Heat or Steam Sterilization

[J021300850000]

Moist Heat or Steam Sterilization

[J021300850000]

Moist Heat or Steam Sterilization

[J021300850000]

Moist Heat or Steam Sterilization

[J021300850000]

Moist Heat or Steam Sterilization

[J021300850000]

Moist Heat or Steam Sterilization

[J021300850000]

Moist Heat or Steam Sterilization

[J021300850000]

Moist Heat or Steam Sterilization

[J021300850000]

Moist Heat or Steam Sterilization

[J021300850000]

Moist Heat or Steam Sterilization

[J021300850000]

Moist Heat or Steam Sterilization

[J021300850000]

Moist Heat or Steam Sterilization

[J021300850000]

Moist Heat or Steam Sterilization

[J021300850000]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-12
• Device Publish Date: 2025-03-04

Devices Manufactured by W & H Dentalwerk Bürmoos GmbH

• J021305000000 - Piezomed Pro M-PM100: 2025-07-16 Piezomed Pro Module
• J021305010000 - Piezomed Pro M-PH350: 2025-07-16 Piezomed Pro Handpiece
• J021305020001 - Piezomed Pro Accessory: 2025-07-16 Instrument MP1
• J021305020011 - Piezomed Pro Accessory: 2025-07-16 Instrument MR1
• J021305020021 - Piezomed Pro Accessory: 2025-07-16 Instrument MR2
• J021305020031 - Piezomed Pro Accessory: 2025-07-16 Instrument MR3
• J021305020041 - Piezomed Pro Accessory: 2025-07-16 Instrument MR4
• J021305020051 - Piezomed Pro Accessory: 2025-07-16 Instrument MR5