EQ-M P2801-US

GUDID 08809455600917

Cordless Endodontic Motor Kit - US

META SYSTEMS CO., LTD.

Dental surgical power tool motorized handpiece/set, electric

Primary Device ID	08809455600917
NIH Device Record Key	89e5d0b5-4299-4196-9eaf-e18b75324e0c
Commercial Distribution Status	In Commercial Distribution
Brand Name	EQ-M
Version Model Number	P2801
Catalog Number	P2801-US
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	08809455600917 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K210475

FDA Product Code

EKX	Handpiece, Direct Drive, Ac-Powered

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[08809455600917]

Moist Heat or Steam Sterilization

[08809455600917]

Moist Heat or Steam Sterilization

[08809455600917]

Moist Heat or Steam Sterilization

[08809455600917]

Moist Heat or Steam Sterilization

[08809455600917]

Moist Heat or Steam Sterilization

[08809455600917]

Moist Heat or Steam Sterilization

[08809455600917]

Moist Heat or Steam Sterilization

[08809455600917]

Moist Heat or Steam Sterilization

[08809455600917]

Moist Heat or Steam Sterilization

[08809455600917]

Moist Heat or Steam Sterilization

[08809455600917]

Moist Heat or Steam Sterilization

[08809455600917]

Moist Heat or Steam Sterilization

[08809455600917]

Moist Heat or Steam Sterilization

[08809455600917]

Moist Heat or Steam Sterilization

[08809455600917]

Moist Heat or Steam Sterilization

[08809455600917]

Moist Heat or Steam Sterilization

[08809455600917]

Moist Heat or Steam Sterilization

[08809455600917]

Moist Heat or Steam Sterilization

[08809455600917]

Moist Heat or Steam Sterilization

[08809455600917]

Moist Heat or Steam Sterilization

[08809455600917]

Moist Heat or Steam Sterilization

[08809455600917]

Moist Heat or Steam Sterilization

[08809455600917]

Moist Heat or Steam Sterilization

[08809455600917]

Moist Heat or Steam Sterilization

[08809455600917]

Moist Heat or Steam Sterilization

[08809455600917]

Moist Heat or Steam Sterilization

[08809455600917]

Moist Heat or Steam Sterilization

[08809455600917]

Moist Heat or Steam Sterilization

[08809455600917]

Moist Heat or Steam Sterilization

[08809455600917]

Moist Heat or Steam Sterilization

[08809455600917]

Moist Heat or Steam Sterilization

[08809455600917]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-07-18
Device Publish Date	2023-07-10

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08809455602089 - Apex ID	2025-01-07 Apex ID is an Electronic Apex Locator designed for use in measuring the working length of root canals.
08809455602096 - Apex ID	2025-01-07 Apex ID is an Electronic Apex Locator designed for use in measuring the working length of root canals.
08809455602102 - Apex ID	2025-01-07 Apex ID is an Electronic Apex Locator designed for use in measuring the working length of root canals.
08809455602119 - Apex ID	2025-01-07 Apex ID is an Electronic Apex Locator designed for use in measuring the working length of root canals.

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