EDEGENDO

GUDID 06944843619057

EDGEAPEX HP Endodontic Motor is cordless endodontic treatment motorized handpiece with root canalmeasurement capability. It can be used for preparation and enlargement of root canals, or measuring the canal length. Andit can be used to enlarge the canals while monitoring the position of the file tip inside the canal.

Guilin Woodpecker Medical Instrument Co., Ltd.

Dental surgical power tool motorized handpiece/set, electric

• Primary Device ID: 06944843619057
• NIH Device Record Key: 5b59835f-45a4-4e9a-a20f-8dcc125e4f95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EDEGENDO
• Version Model Number: EDGEAPEX HP
• 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	06944843619057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203320

FDA Product Code

• EKX: Handpiece, Direct Drive, Ac-Powered

Sterilization

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

[06944843619057]

Moist Heat or Steam Sterilization

[06944843619057]

Moist Heat or Steam Sterilization

[06944843619057]

Moist Heat or Steam Sterilization

[06944843619057]

Moist Heat or Steam Sterilization

[06944843619057]

Moist Heat or Steam Sterilization

[06944843619057]

Moist Heat or Steam Sterilization

[06944843619057]

Moist Heat or Steam Sterilization

[06944843619057]

Moist Heat or Steam Sterilization

[06944843619057]

Moist Heat or Steam Sterilization

[06944843619057]

Moist Heat or Steam Sterilization

[06944843619057]

Moist Heat or Steam Sterilization

[06944843619057]

Moist Heat or Steam Sterilization

[06944843619057]

Moist Heat or Steam Sterilization

[06944843619057]

Moist Heat or Steam Sterilization

[06944843619057]

Moist Heat or Steam Sterilization

[06944843619057]

Moist Heat or Steam Sterilization

[06944843619057]

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