i-ROOT

GUDID 08809455601105

Probe cord

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

• Primary Device ID: 08809455601105
• NIH Device Record Key: 80e90da3-84fd-4420-b8d2-7e4c1fcab47a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-ROOT
• Version Model Number: 404730
• 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	08809455601105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100450

FDA Product Code

• LQY: Locator, Root Apex

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-09
• Device Publish Date: 2021-06-01

On-Brand Devices [i-ROOT]

• 08809455601105: Probe cord
• 08809455601099: Lip holder
• 08809455601082: File holder B
• 08809455601075: File holder A
• 08809455601051: Probe set