Virtual 573527AN

GUDID D707573527EN0

IVOCLAR VIVADENT, INC.

Silicone dental impression material

• Primary Device ID: D707573527EN0
• NIH Device Record Key: d518eec6-0415-4f46-ac35-c2916ee8ccee
• Commercial Distribution Discontinuation: 2020-11-17
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Virtual
• Version Model Number: 573527AN
• Catalog Number: 573527AN
• Company DUNS: 176935203
• Company Name: IVOCLAR VIVADENT, 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: false
• Device Combination Product: false
• Single Use: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D707573527EN0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972027

FDA Product Code

• ELW: MATERIAL, IMPRESSION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2025-05-26
• Device Publish Date: 2017-04-07

On-Brand Devices [Virtual]

• D707573524EN0: 573524AN
• D707573527EN0: 573527AN
• D707562862AN0: 562862AN
• D707562859AN0: 562859AN
• D707562858AN0: 562858AN
• D707562855AN0: 562855AN
• D707562854AN0: 562854AN
• D707562853AN0: 562853AN
• D707562852AN0: 562852AN
• D707562826AN0: 562826AN