HotTip

GUDID 08800019100416

B& L Biotech, inc.

Endodontic obturation system

• Primary Device ID: 08800019100416
• NIH Device Record Key: 68a2af14-77fa-4366-af3b-a48840f01377
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HotTip
• Version Model Number: CL-A1
• Company DUNS: 687338285
• Company Name: B& L Biotech, inc.
• 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: 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	08800019100416 [Primary]

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: 2024-11-27
• Device Publish Date: 2024-11-19

Devices Manufactured by B& L Biotech, inc.

• 08800019115038 - B&L Mirror: 2024-12-27
• 08800019151319 - DS Tip: 2024-12-13
• 08800019151326 - DS Tip: 2024-12-13
• 08800019151333 - DS Tip: 2024-12-13
• 08800019151340 - DS Tip: 2024-12-13
• 08800019151357 - DS Tip: 2024-12-13
• 08800019151364 - DS Tip: 2024-12-13
• 08800019151371 - DS Tip: 2024-12-13