i-ROOT

GUDID 08809455601075

File holder A

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	08809455601075
NIH Device Record Key	4f7e8b03-f746-4b40-833a-c4bf2b867ae2
Commercial Distribution Status	In Commercial Distribution
Brand Name	i-ROOT
Version Model Number	404710
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	08809455601075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K100450

FDA Product Code

LQY	Locator, Root Apex