DENTIOIII series

GUDID 08800005200113

The DENTIOIII is intended for dental radiographic examination of the teeth and temporomandibular joints, specifically for panoramic examinations. It is to be used only by dental practitioners and/or radiologists.

HDX WILL CORP.

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Primary Device ID08800005200113
NIH Device Record Key660c1596-0455-4a9a-ba78-8c7f1b850b20
Commercial Distribution StatusIn Commercial Distribution
Brand NameDENTIOIII series
Version Model NumberDENTIOIII
Company DUNS689605054
Company NameHDX WILL CORP.
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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+82215882754
Emailglobal@hdx.co.kr
Phone+82215882754
Emailglobal@hdx.co.kr
Phone+82215882754
Emailglobal@hdx.co.kr
Phone+82215882754
Emailglobal@hdx.co.kr
Phone+82215882754
Emailglobal@hdx.co.kr
Phone+82215882754
Emailglobal@hdx.co.kr
Phone+82215882754
Emailglobal@hdx.co.kr
Phone+82215882754
Emailglobal@hdx.co.kr
Phone+82215882754
Emailglobal@hdx.co.kr
Phone+82215882754
Emailglobal@hdx.co.kr
Phone+82215882754
Emailglobal@hdx.co.kr
Phone+82215882754
Emailglobal@hdx.co.kr
Phone+82215882754
Emailglobal@hdx.co.kr
Phone+82215882754
Emailglobal@hdx.co.kr
Phone+82215882754
Emailglobal@hdx.co.kr
Phone+82215882754
Emailglobal@hdx.co.kr

Device Identifiers

Device Issuing AgencyDevice ID
GS108800005200113 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUHSystem, X-Ray, Extraoral Source, Digital

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-01-06
Device Publish Date2019-03-04

On-Brand Devices [DENTIOIII series]

08800005200120The DENTIOIII-S is intended for dental radiographic examination of the teeth and temporomandibul
08800005200113The DENTIOIII is intended for dental radiographic examination of the teeth and temporomandibular

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