Edge Taper GP

GUDID 88800069209417

Edge Taper Gutta Percha Points F2

SURE DENT CORPORATION

Synthetic gutta-percha

• Primary Device ID: 88800069209417
• NIH Device Record Key: e3550f7a-64d4-4fb6-9a16-9a4bbd4ef3dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Edge Taper GP
• Version Model Number: ETGPF2-1
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from direct sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800069209411 [Primary]
GS1	88800069209417 [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: 2023-08-24
• Device Publish Date: 2023-08-16

On-Brand Devices [Edge Taper GP]

• 88800069209790: EDGE TAPER GUTTA PERCHA ASSORTED - (F1-F5)
• 88800069209448: Edge Taper Gutta Percha Points F5
• 88800069209431: Edge Taper Gutta Percha Points F4
• 88800069209424: Edge Taper Gutta Percha Points F3
• 88800069209417: Edge Taper Gutta Percha Points F2
• 88800069209400: Edge Taper Gutta Percha Points F1