Edge File X3 X3300629HTS

GUDID 07640452465953

Edge File X3, no 30, 06, 29 mm

FKG Dentaire Sàrl

Rotary/reciprocating endodontic file/rasp, single-use

• Primary Device ID: 07640452465953
• NIH Device Record Key: a00186b8-30db-4666-a3dd-12510b72c047
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Edge File X3
• Version Model Number: X3300629HTS
• Catalog Number: X3300629HTS
• Company DUNS: 482884061
• Company Name: FKG Dentaire Sàrl
• Device Count: 6
• DM Exempt: true
• 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: true
• 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	07640452463485 [Primary]
GS1	07640452465953 [Unit of Use]

FDA Product Code

• EKS: File, Pulp Canal, Endodontic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-15
• Device Publish Date: 2025-12-05

On-Brand Devices [Edge File X3]

• 07640452466677: EdgeFile X3 Assortment 17.04 17.06 20.04 20.06 25.06 30.06, 25mm
• 07640452466660: EdgeFile X3 Assortment 17.04 17.06 20.04 20.06 25.06 30.06, 21mm
• 07640452465977: Edge File X3, no 40, 06, 29 mm
• 07640452465953: Edge File X3, no 30, 06, 29 mm
• 07640452465946: Edge File X3, no 25, 06, 29 mm
• 07640452465939: Edge File X3, no 20, 06, 29 mm
• 07640452466684: Edge File X3, no 17, 06, 29 mm
• 07640452465908: Edge File X3, no 40, 06, 25 mm
• 07640452465885: Edge File X3, no 30, 06, 25 mm
• 00764045246587: Edge File X3, no 25, 06, 25 mm
• 07640452465861: Edge File X3, no 20, 06, 25 mm
• 07640452465830: Edge File X3, no 40, 06, 21 mm
• 07640452465823: Edge File X3, no 30, 06, 21 mm
• 07640452465816: Edge File X3, no 25, 06, 21 mm
• 07640452465809: Edge File X3, no 20, 06, 21 mm
• 07640452465724: Edge File X3, no 17, 04, 29 mm
• 07640452465656: Edge File X3, no 17, 04, 25 mm
• 07640452465595: Edge File X3, no 20, 04, 21 mm
• 07640452465588: Edge File X3, no 17, 04, 21 mm