Bioclear Instrument

GUDID D9495000213

Metal instrument used in dental restorations.

Bioclear Matrix Systems

Dental restoration carver, multiple-material

• Primary Device ID: D9495000213
• NIH Device Record Key: ca1bbd49-4a7f-46bf-a100-6a79eae3c667
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bioclear Instrument
• Version Model Number: Sculpting Point
• 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: false
• 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	D9495000213 [Primary]

FDA Product Code

• DZN: Instruments, Dental Hand

Sterilization

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

[D9495000213]

Moist Heat or Steam Sterilization

[D9495000213]

Moist Heat or Steam Sterilization

[D9495000213]

Moist Heat or Steam Sterilization

[D9495000213]

Moist Heat or Steam Sterilization

[D9495000213]

Moist Heat or Steam Sterilization

[D9495000213]

Moist Heat or Steam Sterilization

[D9495000213]

Moist Heat or Steam Sterilization

[D9495000213]

Moist Heat or Steam Sterilization

[D9495000213]

Moist Heat or Steam Sterilization

[D9495000213]

Moist Heat or Steam Sterilization

[D9495000213]

Moist Heat or Steam Sterilization

[D9495000213]

Moist Heat or Steam Sterilization

[D9495000213]

Moist Heat or Steam Sterilization

[D9495000213]

Moist Heat or Steam Sterilization

[D9495000213]

Moist Heat or Steam Sterilization

[D9495000213]

Moist Heat or Steam Sterilization

[D9495000213]

Moist Heat or Steam Sterilization

[D9495000213]

Moist Heat or Steam Sterilization

[D9495000213]

Moist Heat or Steam Sterilization

[D9495000213]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-19
• Device Publish Date: 2023-09-11

On-Brand Devices [Bioclear Instrument]

• D9495001311: Metal instrument used in dental restorations.
• D9495001221: Plastic instrument used in dental restorations.
• D9495001111: Plastic instrument used in dental restorations.
• D9495001110: Plastic instrument used in dental restorations.
• D9495000811: Metal instrument used in dental restorations.
• D9495000711: Metal instrument used in dental restorations.
• D9495000611: Metal instrument used in dental restorations.
• D9495000511: Metal instrument used in dental restorations.
• D9495000411: Metal instrument used in dental restorations.
• D9495000311: Metal instrument used in dental restorations.
• D9495000211: Metal instrument used in dental restorations.
• D9495000111: Metal instrument used in dental restorations.
• D9495001313: Metal instrument used in dental restorations.
• D9495001223: Plastic instrument used in dental restorations.
• D9495001113: Plastic instrument used in dental restorations.
• D9495000813: Metal instrument used in dental restorations.
• D9495000613: Metal instrument used in dental restorations.
• D9495000413: Metal instrument used in dental restorations.
• D9495000313: Metal instrument used in dental restorations.
• D9495000213: Metal instrument used in dental restorations.
• D9495000113: Metal instrument used in dental restorations.
• D9495000821: Metal instrument used in dental restorations.