EdgeSequel Sapphire ES450421HTS

GUDID 07640452466066

EdgeSequel Sapphire, size 45.04, 21mm

FKG Dentaire Sàrl

Rotary/reciprocating endodontic file/rasp, single-use

• Primary Device ID: 07640452466066
• NIH Device Record Key: 37678d84-d4b4-4f06-9b10-ff8c859d6ec9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EdgeSequel Sapphire
• Version Model Number: ES450421HTS
• Catalog Number: ES450421HTS
• Company DUNS: 482884061
• Company Name: FKG Dentaire Sàrl
• Device Count: 4
• 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	07640452461849 [Primary]
GS1	07640452466066 [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: 2025-11-28
• Device Publish Date: 2025-11-20

On-Brand Devices [EdgeSequel Sapphire]

• 07640452466240: EdgeSequel Sapphire, size 80.04, 25mm
• 07640452466110: EdgeSequel Sapphire, size 80.04, 21mm
• 07640452466363: EdgeSequel Sapphire, size 70.04, 31mm
• 07640452466233: EdgeSequel Sapphire, size 70.04, 25mm
• 07640452466103: EdgeSequel Sapphire, size 70.04, 21mm
• 07640452466356: EdgeSequel Sapphire, size 60.04, 31mm
• 07640452466226: EdgeSequel Sapphire, size 60.04, 25mm
• 07640452466097: EdgeSequel Sapphire, size 60.04, 21mm
• 07640452466349: EdgeSequel Sapphire, size 55.04, 31mm
• 07640452466219: EdgeSequel Sapphire, size 55.04, 25mm
• 07640452466080: EdgeSequel Sapphire, size 55.04, 21mm
• 07640452466622: EdgeSequel Sapphire, size 50.06, 31mm
• 07640452466547: EdgeSequel Sapphire, size 50.06, 25mm
• 07640452466462: EdgeSequel Sapphire, size 50.06, 21mm
• 07640452466332: EdgeSequel Sapphire, size 50.04, 31mm
• 07640452466202: EdgeSequel Sapphire, size 50.04, 25mm
• 07640452466073: EdgeSequel Sapphire, size 50.04, 21mm
• 07640452466615: EdgeSequel Sapphire, size 45.06, 31mm
• 07640452466530: EdgeSequel Sapphire, size 45.06, 25mm
• 07640452466455: EdgeSequel Sapphire, size 45.06, 21mm
• 07640452466325: EdgeSequel Sapphire, size 45.04, 31mm
• 07640452466196: EdgeSequel Sapphire, size 45.04, 25mm
• 07640452466066: EdgeSequel Sapphire, size 45.04, 21mm
• 07640452466608: EdgeSequel Sapphire, size 40.06, 31mm
• 07640452466523: EdgeSequel Sapphire, size 40.06, 25mm
• 07640452466592: EdgeSequel Sapphire .06 Assortment – 035/040/045/050 – 31mm
• 07640452466516: EdgeSequel Sapphire .06 Assortment – 035/040/045/050 – 25mm
• 07640452466431: EdgeSequel Sapphire .06 Assortment – 035/040/045/050 – 21mm
• 07640452466301: EdgeSequel Sapphire .04 Assortment – 035/040/045/050 – 31mm
• 07640452466172: EdgeSequel Sapphire .04 Assortment – 035/040/045/050 – 25mm
• 07640452466042: EdgeSequel Sapphire .04 Assortment – 035/040/045/050 – 21mm
• 07640452466554: EdgeSequel Sapphire .06 Assortment – 015/020/025/030 – 31mm
• 07640452466479: EdgeSequel Sapphire .06 Assortment – 015/020/025/030 – 25mm
• 07640452466394: EdgeSequel Sapphire .06 Assortment – 015/020/025/030 – 21mm
• 07640452466264: EdgeSequel Sapphire .04 Assortment – 015/020/025/030 – 31mm
• 07640452466134: EdgeSequel Sapphire .04 Assortment – 015/020/025/030 – 25mm
• 07640452466387: EdgeSequel Sapphire, size 90.04, 31mm
• 07640452466257: EdgeSequel Sapphire, size 90.04, 25mm
• 07640452466127: EdgeSequel Sapphire, size 90.04, 21mm
• 07640452466370: EdgeSequel Sapphire, size 80.04, 31mm
• 07640452466004: EdgeSequel Sapphire .04 Assortment – 015/020/025/030 – 21mm