EdgeFlow™ EEPTOHIH3

GUDID 00818365028115

EdgeFlow FiE-HS004 Heat Insulation Hood (3 Pack)

US ENDODONTICS, LLC

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• Primary Device ID: 00818365028115
• NIH Device Record Key: fdba0738-b961-43ec-b448-68193cd0bf67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EdgeFlow™
• Version Model Number: EEPTOHIH3
• Catalog Number: EEPTOHIH3
• Company DUNS: 061317427
• Company Name: US ENDODONTICS, LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818365028115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203320

FDA Product Code

• EKX: Handpiece, direct drive, ac-powered

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: 2023-07-03
• Device Publish Date: 2023-06-25

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• 00818365028283: EdgeFlow E23G-M Injection needle
• 00818365028276: EdgeFlow E23G-L Injection needle
• 00818365028269: EdgeFlow E20G-S Injection needle
• 00818365028252: EdgeFlow E20G-NR Injection needle
• 00818365028245: EdgeFlow E20G-M Injection needle
• 00818365028238: EdgeFlow E20G-L Injection needle
• 00818365028115: EdgeFlow FiE-HS004 Heat Insulation Hood (3 Pack)
• 00818365028108: EdgeFlow FiE-HS003 Wrench
• 00818365028092: EdgeFlow FiE-HS002 Battery
• 00818365028085: EdgeFlow FiE-HS001 Charging Stand
• 00818365028078: EdgeFlow Fi-E (Pen-Type Obturator)