Genius Variable Operating System 4056

GUDID 00883205101648

Genius 8:1 Contra-Angle Kit

ULTRADENT PRODUCTS, INC.

Dental laboratory drilling system motor

• Primary Device ID: 00883205101648
• NIH Device Record Key: 6389de13-2c13-4a86-9d4f-8b72c4a080e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genius Variable Operating System
• Version Model Number: 4056
• Catalog Number: 4056
• Company DUNS: 013369913
• Company Name: ULTRADENT PRODUCTS, INC.
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883205101648 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052741

FDA Product Code

• EBW: Controller, foot, handpiece and cord

Sterilization

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

[00883205101648]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-07

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