Biofit BLUE Posterior Kit

GUDID D9498050812

Convenience kit of Bioclear products used in posterior dental restorations.

Bioclear Matrix Systems

Dental matrix band kit

• Primary Device ID: D9498050812
• NIH Device Record Key: 3b5be0f9-ebc7-4327-b081-37317e46683c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biofit BLUE Posterior Kit
• Version Model Number: Complete
• 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: 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	D9498050812 [Primary]

Sterilization

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

[D9498050812]

Moist Heat or Steam Sterilization

[D9498050812]

Moist Heat or Steam Sterilization

[D9498050812]

Moist Heat or Steam Sterilization

[D9498050812]

Moist Heat or Steam Sterilization

[D9498050812]

Moist Heat or Steam Sterilization

[D9498050812]

Moist Heat or Steam Sterilization

[D9498050812]

Moist Heat or Steam Sterilization

[D9498050812]

Moist Heat or Steam Sterilization

[D9498050812]

Moist Heat or Steam Sterilization

[D9498050812]

Moist Heat or Steam Sterilization

[D9498050812]

Moist Heat or Steam Sterilization

[D9498050812]

Moist Heat or Steam Sterilization

[D9498050812]

Moist Heat or Steam Sterilization

[D9498050812]

Moist Heat or Steam Sterilization

[D9498050812]

Moist Heat or Steam Sterilization

[D9498050812]

Moist Heat or Steam Sterilization

[D9498050812]

Moist Heat or Steam Sterilization

[D9498050812]

Moist Heat or Steam Sterilization

[D9498050812]

Moist Heat or Steam Sterilization

[D9498050812]

Moist Heat or Steam Sterilization

[D9498050812]

Moist Heat or Steam Sterilization

[D9498050812]

Moist Heat or Steam Sterilization

[D9498050812]

Moist Heat or Steam Sterilization

[D9498050812]

Moist Heat or Steam Sterilization

[D9498050812]

Moist Heat or Steam Sterilization

[D9498050812]

Moist Heat or Steam Sterilization

[D9498050812]

Moist Heat or Steam Sterilization

[D9498050812]

Moist Heat or Steam Sterilization

[D9498050812]

Moist Heat or Steam Sterilization

[D9498050812]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-18
• Device Publish Date: 2023-09-10

Devices Manufactured by Bioclear Matrix Systems

• D9498271612 - Evolve All-in-One Select Kit: 2024-10-30 Convenience kit of Bioclear products used in posterior dental restorations.
• D9499000412 - BT, Evolve, & DW: 2024-08-28 Samples of Bioclear products used in dental restorations.
• D9498270912 - Evolve Matrix Procedure Kit: 2024-07-18 Convenience kit of Bioclear products used in posterior dental restorations.
• D9495000821 - Bioclear Instrument: 2024-04-15 Metal instrument used in dental restorations.
• D9498271312 - Select Bioclear Evolve Posterior Kit: 2024-04-15 Convenience kit of Bioclear products used in posterior dental restorations.
• D9498271412 - Bioclear Evolve Posterior Kit: 2024-04-15 Convenience kit of Bioclear products used in posterior dental restorations.
• D949208011R1 - Bioclear TwinRing: 2023-09-25 Separator ring used in dental restorations.
• D949208021R1 - Bioclear TwinRing: 2023-09-25 Separator ring used in dental restorations.