EdgeTip™ #8

GUDID 00818365020218

Long Titanium-Niobium tip for retreatment in the apical third and long, straight canals

EDGE ENDO LLC

Ultrasonic dental scaling/debridement system handpiece tip, endodontic Ultrasonic dental scaling/debridement system handpiece tip, endodontic

• Primary Device ID: 00818365020218
• NIH Device Record Key: 001c70a1-7a36-4602-ae7c-9c92902068d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EdgeTip™ #8
• Version Model Number: ET25L
• Company DUNS: 078474365
• Company Name: EDGE ENDO LLC
• Device Count: 1
• DM Exempt: false
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818365020218 [Primary]

FDA Product Code

• ELC: Scaler, Ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-02-21
• Device Publish Date: 2018-06-10

Devices Manufactured by EDGE ENDO LLC

• 00818365021031 - EdgeTemp™ Plus Hydraulic Temporary Restorative Material: 2020-09-07 EdgeTemp™ Plus is used for fabrication of temporary fillings for use until the permanent prosthetic is ready for installation.
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• 10818365020949 - Edge™ EarLoop Procedure Masks: 2020-05-06 Earloop Procedure Masks, ASTM Level 1, Pink, Box
• 10818365020956 - Edge™ EarLoop Procedure Masks: 2020-05-06 Earloop Procedure Masks, ASTM Level 1, Blue, Box
• 10818365020963 - Edge™ EarLoop Procedure Masks: 2020-05-06 Earloop Procedure Masks, ASTM Level 2, White, Box
• 10818365020970 - Edge™ EarLoop Procedure Masks: 2020-05-06 Earloop Procedure Masks, ASTM Level 2, Pink, Box
• 10818365020987 - Edge™ EarLoop Procedure Masks: 2020-05-06 Earloop Procedure Masks, ASTM Level 2, Blue, Box
• 20818365020991 - Edge™ EarLoop Procedure Masks: 2020-05-06 Earloop Procedure Masks, ASTM Level 3, White, Box