Bioclear TwinRing

GUDID D949208021R1

Separator ring used in dental restorations.

Bioclear Matrix Systems

Dental matrix band retainer

• Primary Device ID: D949208021R1
• NIH Device Record Key: 622ca633-897a-4c37-9395-a0be900b5152
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bioclear TwinRing
• Version Model Number: Premolar
• 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	D949208021R1 [Primary]

FDA Product Code

• DZN: Instruments, Dental Hand

Sterilization

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

[D949208021R1]

Moist Heat or Steam Sterilization

[D949208021R1]

Moist Heat or Steam Sterilization

[D949208021R1]

Moist Heat or Steam Sterilization

[D949208021R1]

Moist Heat or Steam Sterilization

[D949208021R1]

Moist Heat or Steam Sterilization

[D949208021R1]

Moist Heat or Steam Sterilization

[D949208021R1]

Moist Heat or Steam Sterilization

[D949208021R1]

Moist Heat or Steam Sterilization

[D949208021R1]

Moist Heat or Steam Sterilization

[D949208021R1]

Moist Heat or Steam Sterilization

[D949208021R1]

Moist Heat or Steam Sterilization

[D949208021R1]

Moist Heat or Steam Sterilization

[D949208021R1]

Moist Heat or Steam Sterilization

[D949208021R1]

Moist Heat or Steam Sterilization

[D949208021R1]

Moist Heat or Steam Sterilization

[D949208021R1]

Moist Heat or Steam Sterilization

[D949208021R1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-25
• Device Publish Date: 2023-09-16

On-Brand Devices [Bioclear TwinRing]

• D9492080210: Separator ring used in dental restorations.
• D9492080110: Separator ring used in dental restorations.
• D9492080421: Separator ring used in dental restorations.
• D9492080420: Separator ring used in dental restorations.
• D949208021R1: Separator ring used in dental restorations.
• D949208011R1: Separator ring used in dental restorations.