B&L-Beta

GUDID 08800019101017

B& L Biotech, inc.

Endodontic obturation system

• Primary Device ID: 08800019101017
• NIH Device Record Key: 5f8fe561-371b-45c8-a15e-b5452a6cbbe9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: B&L-Beta
• Version Model Number: WL-B1
• Company DUNS: 687338285
• Company Name: B& L Biotech, inc.
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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
GS1	08800019101017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060347

FDA Product Code

• EKR: Plugger, Root Canal, Endodontic

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: 2019-05-29
• Device Publish Date: 2019-05-21

On-Brand Devices [B&L-Beta]

• 08800019101017: WL-B1
• 08800019101628: WL-B1