Universal Adapter Entran

GUDID J021052046000

Adapter for Assistina

W & H Dentalwerk Bürmoos GmbH

Surgical power tool maintenance adaptor

• Primary Device ID: J021052046000
• NIH Device Record Key: e879dfe7-429a-44b7-9824-b1c1d17c57f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Universal Adapter Entran
• Version Model Number: 05204600
• 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	J021052046000 [Direct Marking]
HIBCC	J021052046001 [Primary]

FDA Product Code

• EFB: Handpiece, Air-Powered, 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: 2023-07-19
• Device Publish Date: 2023-07-11

Devices Manufactured by W & H Dentalwerk Bürmoos GmbH

• J021020835000 - MCA-RM-BC: 2025-12-10 Assistina Adapter Borden
• J021063951001 - MCA-QC-RM: 2025-12-10 Assistina Adapter Quick RM
• J021064226001 - MCA-QC-ISO: 2025-12-10 Assistina Adapter Quick ISO
• J021305030001 - Piezomed Pro Accessory: 2025-09-30 Instrument MP1-S
• J021305030011 - Piezomed Pro Accessory: 2025-09-30 Instrument MR1-S
• J021305030021 - Piezomed Pro Accessory: 2025-09-30 Instrument MR2-S
• J021305030031 - Piezomed Pro Accessory: 2025-09-30 Instrument MR3-S
• J021305030041 - Piezomed Pro Accessory: 2025-09-30 Instrument MR4-S