Edge X7 GP

GUDID 88800069209127

Edge X7 Gutta Percha Points 20.06

SURE DENT CORPORATION

Synthetic gutta-percha

• Primary Device ID: 88800069209127
• NIH Device Record Key: 3b77bc8b-1fb5-4f2d-8855-0f9590c3b314
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Edge X7 GP
• Version Model Number: X72006GP-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	08800069209121 [Primary]
GS1	88800069209127 [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 X7 GP]

• 88800069209752: EDGE X7 .06 GUTTA PERCHA ASSORTED - (17,20,25,30,35,40)
• 88800069209745: EDGE X7 .04 GUTTA PERCHA ASSORTED - (17,20,25,30,35,40)
• 88800069209172: Edge X7 Gutta Percha Points 45.06
• 88800069209165: Edge X7 Gutta Percha Points 40.06
• 88800069209158: Edge X7 Gutta Percha Points 35.06
• 88800069209141: Edge X7 Gutta Percha Points 30.06
• 88800069209134: Edge X7 Gutta Percha Points 25.06
• 88800069209127: Edge X7 Gutta Percha Points 20.06
• 88800069209110: Edge X7 Gutta Percha Points 17.06
• 88800069209103: Edge X7 Gutta Percha Points 45.04
• 88800069209097: Edge X7 Gutta Percha Points 40.04
• 88800069209080: Edge X7 Gutta Percha Points 35.04
• 88800069209073: Edge X7 Gutta Percha Points 30.04
• 88800069209066: Edge X7 Gutta Percha Points 25.04
• 88800069209059: Edge X7 Gutta Percha Points 20.04
• 88800069209042: Edge X7 Gutta Percha Points 17.04