BioUniversal PKF 579876

GUDID D7075798760

BioUniversal PKF 1oz/31 g

IVOCLAR VIVADENT, INC.

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• Primary Device ID: D7075798760
• NIH Device Record Key: 56b54df8-9faa-4e41-8d36-c795fe7c19f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioUniversal PKF
• Version Model Number: 579876
• Catalog Number: 579876
• Company DUNS: 176935203
• Company Name: IVOCLAR VIVADENT, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Serial Number: false
• 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	D7075798760 [Primary]

FDA Product Code

• EJT: Alloy, gold-based noble metal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-04-27
• Device Publish Date: 2018-10-29

On-Brand Devices [BioUniversal PKF]

• D7075841520: 584152
• D7075773510: BioUniversal PKF 100 g
• D7075773500: BioUniversal PKF 25 g
• D7075798760: BioUniversal PKF 1oz/31 g
• D7075798740: BioUniversal PKF 5 g