Medidenta

GUDID 06944843605562

Dental power tool system handpiece, remotely-driven

Guilin Woodpecker Medical Instrument Co., Ltd.

Dental power tool system handpiece, remotely-driven

• Primary Device ID: 06944843605562
• NIH Device Record Key: 86460969-f706-4092-b0ef-103bbc9c2027
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medidenta
• Version Model Number: ACE
• 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	06944843605562 [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

[06944843605562]

Moist Heat or Steam Sterilization

[06944843605562]

Moist Heat or Steam Sterilization

[06944843605562]

Moist Heat or Steam Sterilization

[06944843605562]

Moist Heat or Steam Sterilization

[06944843605562]

Moist Heat or Steam Sterilization

[06944843605562]

Moist Heat or Steam Sterilization

[06944843605562]

Moist Heat or Steam Sterilization

[06944843605562]

Moist Heat or Steam Sterilization

[06944843605562]

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

On-Brand Devices [Medidenta]

• 06944843605579: Apex locator, endodontic
• 06944843605562: Dental power tool system handpiece, remotely-driven
• 06944843605555: Ultrasonic dental scaling/debridement system