Fusion I Seal 30003-1

GUDID D967300031

PREVEST DENPRO LIMITED

Dental composite resin kit

• Primary Device ID: D967300031
• NIH Device Record Key: d64545e7-0018-40cd-af85-fc522f28891b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fusion I Seal
• Version Model Number: Regular Pack
• Catalog Number: 30003-1
• 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	D967300031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231263

FDA Product Code

• EBF: Material, Tooth Shade, 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 [Fusion I Seal]

• D967300032: Large Pack
• D967300031: Regular Pack
• D96730003: Economy Pack
• D967300021: Trial Pack
• D96730002: Intro Pack