Bioclear TwinRing Molar/Premolar Pack

GUDID D949208031K1

Separator ring used in dental restorations.

Bioclear Matrix Systems

Dental matrix band retainer

• Primary Device ID: D949208031K1
• NIH Device Record Key: 7cdbaa50-8ff3-4888-8258-5cb7301ba133
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bioclear TwinRing Molar/Premolar Pack
• Version Model Number: Molar/Premolar Pack
• 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	D949208031K1 [Primary]

FDA Product Code

• DZN: Instruments, Dental Hand

Sterilization

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

[D949208031K1]

Moist Heat or Steam Sterilization

[D949208031K1]

Moist Heat or Steam Sterilization

[D949208031K1]

Moist Heat or Steam Sterilization

[D949208031K1]

Moist Heat or Steam Sterilization

[D949208031K1]

Moist Heat or Steam Sterilization

[D949208031K1]

Moist Heat or Steam Sterilization

[D949208031K1]

Moist Heat or Steam Sterilization

[D949208031K1]

Moist Heat or Steam Sterilization

[D949208031K1]

Moist Heat or Steam Sterilization

[D949208031K1]

Moist Heat or Steam Sterilization

[D949208031K1]

Moist Heat or Steam Sterilization

[D949208031K1]

Moist Heat or Steam Sterilization

[D949208031K1]

Moist Heat or Steam Sterilization

[D949208031K1]

Moist Heat or Steam Sterilization

[D949208031K1]

Moist Heat or Steam Sterilization

[D949208031K1]

Moist Heat or Steam Sterilization

[D949208031K1]

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 Molar/Premolar Pack]

• D949208031K1: Separator ring used in dental restorations.
• D9492080311: Separator ring used in dental restorations.