BioUniversal PKF 584152

GUDID D7075841520

IVOCLAR VIVADENT, INC.

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• Primary Device ID: D7075841520
• NIH Device Record Key: 2b16d631-ba1d-4ef8-8777-2596d78f6502
• Commercial Distribution Discontinuation: 2021-06-29
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: BioUniversal PKF
• Version Model Number: 584152
• Catalog Number: 584152
• 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	D7075841520 [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: 3
• Public Version Date: 2021-07-01
• Device Publish Date: 2017-01-27

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