XP-4D

GUDID 88404535012114

XP-4D Bio GP Cones STANDARD

SURE DENT CORPORATION

Synthetic gutta-percha

• Primary Device ID: 88404535012114
• NIH Device Record Key: 9d94380a-ee6b-4423-b68e-194c287a98db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XP-4D
• Version Model Number: 5031701U0
• 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	08404535012118 [Primary]
GS1	88404535012114 [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: 2025-02-10
• Device Publish Date: 2025-01-31

On-Brand Devices [XP-4D]

• 88800069204894: XP-4D Absorbent Paper Points LARGE
• 88800069204887: XP-4D Absorbent Paper Points LARGE
• 88800069204870: XP-4D Absorbent Paper Points MEDIUM
• 88800069204863: XP-4D Absorbent Paper Points STANDARD
• 88800069204856: XP-4D Absorbent Paper Points STARTER
• 88800069204849: XP-4D Bio Gutta-Percha Cones Assorted (S,M,L)
• 88800069204832: XP-4D Bio Gutta-Percha Cones LARGE
• 88800069204825: XP-4D Bio Gutta-Percha Cones MEDIUM
• 88800069204818: XP-4D Bio Gutta-Percha Cones STANDARD
• 88800069204801: XP-4D Bio Gutta-Percha Cones STARTER
• 88404535012350: XP-4D Absorbent Paper Points Assorted (S,M,L)
• 88404535012329: XP-4D Absorbent Paper Points LARGE
• 88404535012299: XP-4D Absorbent Paper Points MEDIUM
• 88404535012268: XP-4D Absorbent Paper Points STANDARD
• 88404535012237: XP-4D Absorbent Paper Points STARTER
• 88404535012206: XP-4D Bio GP Cones Assorted (S,M,L)
• 88404535012176: XP-4D Bio GP Cones LARGE
• 88404535012145: XP-4D Bio GP Cones MEDIUM
• 88404535012114: XP-4D Bio GP Cones STANDARD
• 88404535012084: XP-4D Bio GP Cones STARTER