PacDent

GUDID 06944843605760

Dental power tool system handpiece, remotely-driven

Guilin Woodpecker Medical Instrument Co., Ltd.

Dental power tool system handpiece, remotely-driven

• Primary Device ID: 06944843605760
• NIH Device Record Key: 51922063-c5c5-4563-923e-9c4c1be7a9ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PacDent
• Version Model Number: iRoot Pro Plus
• 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: 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	06944843605760 [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

[06944843605760]

Moist Heat or Steam Sterilization

[06944843605760]

Moist Heat or Steam Sterilization

[06944843605760]

Moist Heat or Steam Sterilization

[06944843605760]

Moist Heat or Steam Sterilization

[06944843605760]

Moist Heat or Steam Sterilization

[06944843605760]

Moist Heat or Steam Sterilization

[06944843605760]

Moist Heat or Steam Sterilization

[06944843605760]

Moist Heat or Steam Sterilization

[06944843605760]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-02
• Device Publish Date: 2021-08-25

Devices Manufactured by Guilin Woodpecker Medical Instrument Co., Ltd.

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• 06944843619071 - EDEGENDO: 2025-03-19 EDGEPACK is used to provide heat to the Work Tip, cut the gutta-percha point, and soften and pressurize the gutta-percha.
• 06944843619088 - EDEGENDO: 2025-03-19 Heat up and soften gutta-percha, and fill the gutta-percha into the root canal after preparation.
• 06944843619095 - EDEGENDO: 2025-03-19 EDGEAPEX is a microprocessor controlled device intended for locating the apex of root canal.
• 06944843605982 - woodpecker: 2024-10-28 Cordless Prophy System
• 06944843611587 - woodpecker: 2024-10-28 Dental Air Polisher
• 06944843611594 - DTE: 2024-10-28 Dental Air Polisher
• 06944843611600 - woodpecker: 2024-10-28 Dental Scaler and Air Polisher