POMO Black

GUDID 08800019110651

B& L Biotech, inc.

Dental material heater

• Primary Device ID: 08800019110651
• NIH Device Record Key: 3d806fef-bf35-47d6-9bd5-a22a0e218486
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POMO Black
• Version Model Number: POMB
• 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	08800019110651 [Primary]

FDA Product Code

• KXR: Applicator, Resin

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: 2023-06-23
• Device Publish Date: 2023-06-15

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