Biofit HD Posterior Kit

GUDID D9498180012

Convenience kit of Bioclear products used in posterior dental restorations.

Bioclear Matrix Systems

Dental matrix band kit

• Primary Device ID: D9498180012
• NIH Device Record Key: 955f1322-6abd-4052-bc83-42f84d6116e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biofit HD Posterior Kit
• Version Model Number: Mini
• Company DUNS: 059020838
• Company Name: Bioclear Matrix Systems
• 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: true
• 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	D9498180012 [Primary]

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 Posterior Kit]

• D9498180812: Convenience kit of Bioclear products used in posterior dental restorations.
• D9498180032: Convenience kit of Bioclear products used in posterior dental restorations.
• D9498180022: Convenience kit of Bioclear products used in posterior dental restorations.
• D9498180012: Convenience kit of Bioclear products used in posterior dental restorations.