Elements Connect

GUDID 08809455601952

Elements Connect Charging Base

META SYSTEMS CO., LTD.

Dental surgical power tool motorized handpiece/set, electric

• Primary Device ID: 08809455601952
• NIH Device Record Key: 6118c4f1-25ad-48d6-a23e-c7ed3881d630
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elements Connect
• Version Model Number: 815-1809
• 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: true
• Manufacturing Date: true
• 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	08809455601952 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210475

FDA Product Code

• EKX: Handpiece, Direct Drive, Ac-Powered

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: 2022-11-25
• Device Publish Date: 2022-11-17

On-Brand Devices [Elements Connect]

• 08809455601952: Elements Connect Charging Base
• 08809455601945: Elements Connect Contra Angle
• 08809455601938: Elements Connect Motor Handpiece
• 08809455601921: Elements Connect Cordless Motor Kit - US
• 08809455601402: Elements Connect Cordless Motor Kit - EU