i-ROOT 100

GUDID 08809455600641

FILE HOLDER A FOR IROOT 100

META SYSTEMS CO., LTD.

Endodontic apex locator Endodontic apex locator Endodontic apex locator Endodontic apex locator Endodontic apex locator Endodontic apex locator Endodontic apex locator Endodontic apex locator Endodontic apex locator Endodontic apex locator Endodontic apex locator Endodontic apex locator Endodontic apex locator Endodontic apex locator Endodontic apex locator Endodontic apex locator Endodontic apex locator

• Primary Device ID: 08809455600641
• NIH Device Record Key: 3d7b0af3-737d-48b9-bc22-d1bf3492644f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-ROOT 100
• Version Model Number: iRB-008
• 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	08809455600641 [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

[08809455600641]

Moist Heat or Steam Sterilization

[08809455600641]

Moist Heat or Steam Sterilization

[08809455600641]

Moist Heat or Steam Sterilization

[08809455600641]

Moist Heat or Steam Sterilization

[08809455600641]

Moist Heat or Steam Sterilization

[08809455600641]

Moist Heat or Steam Sterilization

[08809455600641]

Moist Heat or Steam Sterilization

[08809455600641]

Moist Heat or Steam Sterilization

[08809455600641]

Moist Heat or Steam Sterilization

[08809455600641]

Moist Heat or Steam Sterilization

[08809455600641]

Moist Heat or Steam Sterilization

[08809455600641]

Moist Heat or Steam Sterilization

[08809455600641]

Moist Heat or Steam Sterilization

[08809455600641]

Moist Heat or Steam Sterilization

[08809455600641]

Moist Heat or Steam Sterilization

[08809455600641]

Moist Heat or Steam Sterilization

[08809455600641]

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