Renew Universal 10018

GUDID D96710018

PREVEST DENPRO LIMITED

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• Primary Device ID: D96710018
• NIH Device Record Key: a56e3aad-b26b-463e-b346-d38aa5a5d5a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Renew Universal
• Version Model Number: Regular Pack
• Catalog Number: 10018
• Company DUNS: 859546940
• Company Name: PREVEST DENPRO LIMITED
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	D96710018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231696

FDA Product Code

• KLE: Agent, Tooth Bonding, Resin

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: 2024-05-01
• Device Publish Date: 2024-04-23

On-Brand Devices [Renew Universal]

• D96710019: Economy Pack
• D96710018: Regular Pack
• D96710017: Intro Pack