B-4U Gutta Percha Points

GUDID 88800069204795

SURE DENT CORPORATION

Synthetic gutta-percha

• Primary Device ID: 88800069204795
• NIH Device Record Key: 5af39c1d-877b-4c0a-8e36-56fc88abc862
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: B-4U Gutta Percha Points
• Version Model Number: G906 LBF12/Finisher L
• Company DUNS: 688273010
• Company Name: SURE DENT CORPORATION
• Device Count: 60
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800069204799 [Primary]
GS1	88800069204795 [Unit of Use]

FDA Product Code

• EKM: Gutta-Percha

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: 2025-04-11
• Device Publish Date: 2025-04-03

On-Brand Devices [B-4U Gutta Percha Points]

• 88800069205006: G906 LBF12/Finisher Asst
• 88800069204795: G906 LBF12/Finisher L
• 88800069204788: G906 LBF12/Finisher M
• 88800069204771: G906 LBF12/Finisher