Original Posterior Matrix M Series

GUDID D949304011B0

Clear matrix used in dental restorations.

Bioclear Matrix Systems

Dental matrix band, single-use

• Primary Device ID: D949304011B0
• NIH Device Record Key: c57c19fa-df94-4949-85ff-c64e50734c40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Original Posterior Matrix M Series
• Version Model Number: M401 Blue
• 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	D94930401125B1 [Primary]
HIBCC	D94930401150B1 [Primary]
HIBCC	D949304011B0 [Unit of Use]

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 [Original Posterior Matrix M Series]

• D949304061C0: Clear matrix used in dental restorations.
• D949304061B0: Clear matrix used in dental restorations.
• D949304051C0: Clear matrix used in dental restorations.
• D949304051B0: Clear matrix used in dental restorations.
• D949304041C0: Clear matrix used in dental restorations.
• D949304041B0: Clear matrix used in dental restorations.
• D949304031C0: Clear matrix used in dental restorations.
• D949304031B0: Clear matrix used in dental restorations.
• D949304021C0: Clear matrix used in dental restorations.
• D949304021B0: Clear matrix used in dental restorations.
• D949304011C0: Clear matrix used in dental restorations.
• D949304011B0: Clear matrix used in dental restorations.