Bioclear Diamond Wedge

GUDID D949112011501

Plastic wedge used in dental restorations.

Bioclear Matrix Systems

Dental wedge, single-use

• Primary Device ID: D949112011501
• NIH Device Record Key: 988f4ecb-f891-418e-adc0-a467ca8dd963
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bioclear Diamond Wedge
• Version Model Number: Small
• Company DUNS: 059020838
• Company Name: Bioclear Matrix Systems
• Device Count: 50
• 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: true
• 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	D9491120110 [Unit of Use]
HIBCC	D949112011501 [Primary]

FDA Product Code

• EJB: Handle, Instrument, Dental

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-15
• Device Publish Date: 2023-08-07

On-Brand Devices [Bioclear Diamond Wedge]

• D9491120510: Plastic wedge used in dental restorations.
• D9491120410: Plastic wedge used in dental restorations.
• D9491120310: Plastic wedge used in dental restorations.
• D9491120210: Plastic wedge used in dental restorations.
• D949112011501: Plastic wedge used in dental restorations.
• D9491120110: Plastic wedge used in dental restorations.