i-ROOT 100

GUDID 08809455600658

FILE HOLDER B FOR IROOT 100

META SYSTEMS CO., LTD.

Endodontic apex locator

• Primary Device ID: 08809455600658
• NIH Device Record Key: b5d66993-7a37-4f38-a1b7-989cc5ac5f7c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-ROOT 100
• Version Model Number: iRB-009
• Company DUNS: 687503532
• Company Name: META SYSTEMS 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: 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	08809455600658 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112508

FDA Product Code

• LQY: Locator, Root Apex

Sterilization

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

[08809455600658]

Moist Heat or Steam Sterilization

[08809455600658]

Moist Heat or Steam Sterilization

[08809455600658]

Moist Heat or Steam Sterilization

[08809455600658]

Moist Heat or Steam Sterilization

[08809455600658]

Moist Heat or Steam Sterilization

[08809455600658]

Moist Heat or Steam Sterilization

[08809455600658]

Moist Heat or Steam Sterilization

[08809455600658]

Moist Heat or Steam Sterilization

[08809455600658]

Moist Heat or Steam Sterilization

[08809455600658]

Moist Heat or Steam Sterilization

[08809455600658]

Moist Heat or Steam Sterilization

[08809455600658]

Moist Heat or Steam Sterilization

[08809455600658]

Moist Heat or Steam Sterilization

[08809455600658]

Moist Heat or Steam Sterilization

[08809455600658]

Moist Heat or Steam Sterilization

[08809455600658]

Moist Heat or Steam Sterilization

[08809455600658]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-10
• Device Publish Date: 2020-03-02

On-Brand Devices [i-ROOT 100]

• 08809455600672: PROBE CORD FOR IROOT 100
• 08809455600665: LIP HOLDER FOR IROOT 100
• 08809455600658: FILE HOLDER B FOR IROOT 100
• 08809455600641: FILE HOLDER A FOR IROOT 100
• 08809455600634: i-ROOT 100