EDEGENDO

GUDID 06944843619095

EDGEAPEX is a microprocessor controlled device intended for locating the apex of root canal.

Guilin Woodpecker Medical Instrument Co., Ltd.

Endodontic apex locator

• Primary Device ID: 06944843619095
• NIH Device Record Key: 317ab042-a995-4f14-8a48-d057475ce94b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EDEGENDO
• Version Model Number: EDGEAPEX
• Company DUNS: 545272577
• Company Name: Guilin Woodpecker Medical Instrument Co., Ltd.
• 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: false
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944843619095 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181087

FDA Product Code

• LQY: Locator, Root Apex

Sterilization

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

[06944843619095]

Moist Heat or Steam Sterilization

[06944843619095]

Moist Heat or Steam Sterilization

[06944843619095]

Moist Heat or Steam Sterilization

[06944843619095]

Moist Heat or Steam Sterilization

[06944843619095]

Moist Heat or Steam Sterilization

[06944843619095]

Moist Heat or Steam Sterilization

[06944843619095]

Moist Heat or Steam Sterilization

[06944843619095]

Moist Heat or Steam Sterilization

[06944843619095]

Moist Heat or Steam Sterilization

[06944843619095]

Moist Heat or Steam Sterilization

[06944843619095]

Moist Heat or Steam Sterilization

[06944843619095]

Moist Heat or Steam Sterilization

[06944843619095]

Moist Heat or Steam Sterilization

[06944843619095]

Moist Heat or Steam Sterilization

[06944843619095]

Moist Heat or Steam Sterilization

[06944843619095]

Moist Heat or Steam Sterilization

[06944843619095]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-19
• Device Publish Date: 2025-03-11

On-Brand Devices [EDEGENDO]

• 06944843619095: EDGEAPEX is a microprocessor controlled device intended for locating the apex of root canal.
• 06944843619088: Heat up and soften gutta-percha, and fill the gutta-percha into the root canal after preparation
• 06944843619071: EDGEPACK is used to provide heat to the Work Tip, cut the gutta-percha point, and soften and pre
• 06944843619057: EDGEAPEX HP Endodontic Motor is cordless endodontic treatment motorized handpiece with root cana