Bioclear Evolve

GUDID D9493271510

Clear matrix used in dental restorations.

Bioclear Matrix Systems

Dental matrix band, single-use

• Primary Device ID: D9493271510
• NIH Device Record Key: e9beffa8-94f8-4370-bf14-50026166f1ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bioclear Evolve
• Version Model Number: Orange 9mm
• 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	D9493271510 [Unit of Use]
HIBCC	D949327151251 [Primary]
HIBCC	D949327151253 [Primary]
HIBCC	D949327151501 [Primary]
HIBCC	D949327151503 [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: 2023-08-18
• Device Publish Date: 2023-08-10

On-Brand Devices [Bioclear Evolve]

• D9493271510: Clear matrix used in dental restorations.
• D9493271410: Clear matrix used in dental restorations.
• D9493271310: Clear matrix used in dental restorations.
• D9493271010: Clear matrix used in dental restorations.
• D9493270810: Clear matrix used in dental restorations.
• D9493270710: Clear matrix used in dental restorations.
• D9493270520: Clear matrix used in dental restorations.
• D9493270420: Clear matrix used in dental restorations.
• D9493270320: Clear matrix used in dental restorations.
• D9493270220: Clear matrix used in dental restorations.
• D9493270120: Clear matrix used in dental restorations.
• D9492372610: Clear matrix used in dental restorations.
• D9493272410: Clear matrix used in dental restorations.
• D9493272310: Clear matrix used in dental restorations.
• D9493272210: Clear matrix used in dental restorations.
• D9493272110: Clear matrix used in dental restorations.