EQ-PEX

GUDID 08809455601167

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 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: 08809455601167
• NIH Device Record Key: 5c92628f-bd49-4722-96a9-bda6542ff426
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EQ-PEX
• Version Model Number: P2901
• Company DUNS: 687503532
• Company Name: META SYSTEMS CO., LTD.
• Device Count: 1
• DM Exempt: true
• 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	08809455601167 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210789

FDA Product Code

• LQY: Locator, Root Apex

Sterilization

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

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-18
• Device Publish Date: 2022-01-10

Devices Manufactured by META SYSTEMS CO., LTD.

• 08809455600917 - EQ-M: 2023-07-18 Cordless Endodontic Motor Kit - US
• 08809455601402 - Elements Connect: 2022-11-25 Elements Connect Cordless Motor Kit - EU
• 08809455601921 - Elements Connect: 2022-11-25 Elements Connect Cordless Motor Kit - US
• 08809455601938 - Elements Connect: 2022-11-25 Elements Connect Motor Handpiece
• 08809455601945 - Elements Connect: 2022-11-25 Elements Connect Contra Angle
• 08809455601952 - Elements Connect: 2022-11-25 Elements Connect Charging Base
• 08809455601419 - Apex Connect: 2022-11-24 Apex Connect Kit - EU
• 08809455601969 - Apex Connect: 2022-11-24 Apex Connect Kit - US