Instrument Set

GUDID D9498000112

Convenience kit of Bioclear products used in dental restorations.

Bioclear Matrix Systems

Manual non-rotary dental instrument handle

• Primary Device ID: D9498000112
• NIH Device Record Key: d94429a7-dae7-4631-9992-aaa0a58cf6f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Instrument Set
• Version Model Number: Elite
• Company DUNS: 059020838
• Company Name: Bioclear Matrix Systems
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• 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	D9498000112 [Primary]

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[D9498000112]

Moist Heat or Steam Sterilization

[D9498000112]

Moist Heat or Steam Sterilization

[D9498000112]

Moist Heat or Steam Sterilization

[D9498000112]

Moist Heat or Steam Sterilization

[D9498000112]

Moist Heat or Steam Sterilization

[D9498000112]

Moist Heat or Steam Sterilization

[D9498000112]

Moist Heat or Steam Sterilization

[D9498000112]

Moist Heat or Steam Sterilization

[D9498000112]

Moist Heat or Steam Sterilization

[D9498000112]

Moist Heat or Steam Sterilization

[D9498000112]

Moist Heat or Steam Sterilization

[D9498000112]

Moist Heat or Steam Sterilization

[D9498000112]

Moist Heat or Steam Sterilization

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 [Instrument Set]

• D9498000212: Convenience kit of Bioclear products used in dental restorations.
• D9498000112: Convenience kit of Bioclear products used in dental restorations.
• D9498000213: Convenience kit of Bioclear products used in dental restorations.