Biofit HD Matrix

GUDID D9493180110

Clear matrix used in dental restorations.

Bioclear Matrix Systems

Dental matrix band, single-use

• Primary Device ID: D9493180110
• NIH Device Record Key: 2196cb0c-d7c7-4093-8c14-26c8380b209b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biofit HD Matrix
• Version Model Number: 4.5 mm Molar
• Company DUNS: 059020838
• Company Name: Bioclear Matrix Systems
• Device Count: 50
• 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: true
• Lot Batch: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D9493180110 [Unit of Use]
HIBCC	D949318011251 [Primary]
HIBCC	D949318011253 [Primary]
HIBCC	D949318011501 [Primary]
HIBCC	D949318011503 [Primary]

FDA Product Code

• JEP: Retainer, Matrix

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: 2023-09-19
• Device Publish Date: 2023-09-11

On-Brand Devices [Biofit HD Matrix]

• D9493180410: Clear matrix used in dental restorations.
• D9493180310: Clear matrix used in dental restorations.
• D9493180210: Clear matrix used in dental restorations.
• D9493180110: Clear matrix used in dental restorations.