Real Arch

GUDID 08800005200182

Real Arch is a dental 3D scanner intended to be used to digitally record topographical characteristics of teeth and surrounding tissues.The Real Arch is composed of a hand-piece, power hub, adapter and usb3.0 cable. The system produces 3D scans for use in computer- assisted design and manufacturing of dental restorations.

HDX WILL CORP.

Intraoral optical scanning system
Primary Device ID08800005200182
NIH Device Record Keyec00d389-9ae6-461f-9c03-21464073e029
Commercial Distribution StatusIn Commercial Distribution
Brand NameReal Arch
Version Model NumberReal Arch
Company DUNS689605054
Company NameHDX WILL CORP.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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+82220035778
Emailjason@hdx.co.kr
Phone+82220035778
Emailjason@hdx.co.kr
Phone+82220035778
Emailjason@hdx.co.kr
Phone+82220035778
Emailjason@hdx.co.kr
Phone+82220035778
Emailjason@hdx.co.kr
Phone+82220035778
Emailjason@hdx.co.kr
Phone+82220035778
Emailjason@hdx.co.kr
Phone+82220035778
Emailjason@hdx.co.kr
Phone+82220035778
Emailjason@hdx.co.kr
Phone+82220035778
Emailjason@hdx.co.kr
Phone+82220035778
Emailjason@hdx.co.kr
Phone+82220035778
Emailjason@hdx.co.kr
Phone+82220035778
Emailjason@hdx.co.kr
Phone+82220035778
Emailjason@hdx.co.kr
Phone+82220035778
Emailjason@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
Phone+82215882754
Emailglobal@hdx.co.kr

Device Identifiers

Device Issuing AgencyDevice ID
GS108800005200182 [Primary]

FDA Product Code

NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800005200182]

Moist Heat or Steam Sterilization

[08800005200182]

Moist Heat or Steam Sterilization

[08800005200182]

Moist Heat or Steam Sterilization

[08800005200182]

Moist Heat or Steam Sterilization

[08800005200182]

Moist Heat or Steam Sterilization

[08800005200182]

Moist Heat or Steam Sterilization

[08800005200182]

Moist Heat or Steam Sterilization

[08800005200182]

Moist Heat or Steam Sterilization

[08800005200182]

Moist Heat or Steam Sterilization

[08800005200182]

Moist Heat or Steam Sterilization

[08800005200182]

Moist Heat or Steam Sterilization

[08800005200182]

Moist Heat or Steam Sterilization

[08800005200182]

Moist Heat or Steam Sterilization

[08800005200182]

Moist Heat or Steam Sterilization

[08800005200182]

Moist Heat or Steam Sterilization

[08800005200182]

Moist Heat or Steam Sterilization

[08800005200182]

Moist Heat or Steam Sterilization

[08800005200182]

Moist Heat or Steam Sterilization

[08800005200182]

Moist Heat or Steam Sterilization

[08800005200182]

Moist Heat or Steam Sterilization

[08800005200182]

Moist Heat or Steam Sterilization

[08800005200182]

Moist Heat or Steam Sterilization

[08800005200182]

Moist Heat or Steam Sterilization

[08800005200182]

Moist Heat or Steam Sterilization

[08800005200182]

Moist Heat or Steam Sterilization

[08800005200182]

Moist Heat or Steam Sterilization

[08800005200182]

Moist Heat or Steam Sterilization

[08800005200182]

Moist Heat or Steam Sterilization

[08800005200182]

Moist Heat or Steam Sterilization

[08800005200182]

Moist Heat or Steam Sterilization

[08800005200182]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-12
Device Publish Date2021-01-04

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08800005200434 - DENTRI Max2022-05-09 The DENTRI Max is a Computed Tomography X-Ray imaging device specialized in diagnosing general dental treatments and orthodontic
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08800005200205 - eco-x series2022-03-01 'eco-x series (eco-x, eco-x-s)' is 4 in 1 digital equipment that provides CT, Panoramic, Cephalometric, and Model Scan images by
08800005200380 - DENTRIα series2022-02-17 The DENTRIα series is a Computed Tomography X-Ray imaging device specialized in diagnosing general dental treatments and orthod
08800005200397 - DENTRIα series2022-02-17 The DENTRIα series is a Computed Tomography X-Ray imaging device specialized in diagnosing general dental treatments and orthod
08800005200403 - DENTRIα series2022-02-17 The DENTRIα series is a Computed Tomography X-Ray imaging device specialized in diagnosing general dental treatments and orthod
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