Edge Apex™ EEALULH5

GUDID 10818365028921

Edge Apex Lip Hook (x5)

US ENDODONTICS, LLC

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• Primary Device ID: 10818365028921
• NIH Device Record Key: 5fe29a47-8f9f-442d-a89c-919d465c74ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Edge Apex™
• Version Model Number: EEALULH5
• Catalog Number: EEALULH5
• Company DUNS: 061317427
• Company Name: US ENDODONTICS, LLC
• Device Count: 5
• 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	00818365028924 [Primary]
GS1	10818365028921 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181087

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

On-Brand Devices [Edge Apex™]

• 00818365028962: Edge Apex Tester
• 00818365028955: Edge Apex Measuring Wire
• 00818365028948: Edge Apex Measuring File
• 00818365028931: Edge Apex Lithium Battery
• 10818365028921: Edge Apex Lip Hook (x5)
• 00818365028900: Edge Apex Endo Ruler