i-ROOT

GUDID 08809455601075

File holder A

META SYSTEMS CO., LTD.

Endodontic apex locator
Primary Device ID08809455601075
NIH Device Record Key4f7e8b03-f746-4b40-833a-c4bf2b867ae2
Commercial Distribution StatusIn Commercial Distribution
Brand Namei-ROOT
Version Model Number404710
Company DUNS687503532
Company NameMETA SYSTEMS CO., LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809455601075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LQYLocator, Root Apex

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809455601075]

Moist Heat or Steam Sterilization


[08809455601075]

Moist Heat or Steam Sterilization


[08809455601075]

Moist Heat or Steam Sterilization


[08809455601075]

Moist Heat or Steam Sterilization


[08809455601075]

Moist Heat or Steam Sterilization


[08809455601075]

Moist Heat or Steam Sterilization


[08809455601075]

Moist Heat or Steam Sterilization


[08809455601075]

Moist Heat or Steam Sterilization


[08809455601075]

Moist Heat or Steam Sterilization


[08809455601075]

Moist Heat or Steam Sterilization


[08809455601075]

Moist Heat or Steam Sterilization


[08809455601075]

Moist Heat or Steam Sterilization


[08809455601075]

Moist Heat or Steam Sterilization


[08809455601075]

Moist Heat or Steam Sterilization


[08809455601075]

Moist Heat or Steam Sterilization


[08809455601075]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-09
Device Publish Date2021-06-01

On-Brand Devices [i-ROOT]

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

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