eco-x series

Primary DI
08800005200199
Brand
eco-x series
Company
HDX WILL CORP.
Model
eco-x
Device description
'eco-x series (eco-x, eco-x-s)' is 4 in 1 digital equipment that provides CT, Panoramic, Cephalometric, and Model Scan images by using X-Ray scan. It provides 2D images for diagnosing cranial bone tissue including adult and pediatric teeth, jaw, and oral structures and skull. Also, it provides 3D images by reconstructing images acquired by capturing cervical bone and occipital regions.In addition, 'eco-x series' is used as diagnosis for general and/or orthodontic treatment, and also is intended to use for ENT (Ear, Nose, and Throat) and dentomaxillofacial diagnosis.
Published
2022-02-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OASX-Ray, Tomography, Computed, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OASX-Ray, Tomography, Computed, DentalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211159000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211159000eco-x Series (eco-x, eco-x-s)Hdx Will Corp.2021-12-30OAS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800005200199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800005200199088000052001998800005200199

GMDN Terms#

Term, Definition table
TermDefinition
Stationary panoramic/tomographic dental x-ray system, digitalA diagnostic digital dental x-ray system designed for permanent fixture in one location with an extraoral x-ray sensor and source intended to generate and control x-ray beams used in advanced dental imaging applications involving the teeth, jaw, oral cavity, sinus, and/or other maxillofacial structures. It uses digital techniques for image capture, manipulation and display and may include various image processing and analysis capabilities. This system is designed with the capability to produce two or more special purpose dental x-ray examinations: linear scanning, panoramic, cephalometric, linear tomography, spiral tomography, scanograms.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+82215882754global@hdx.co.kr

Regulatory Flags#

DUNS number
689605054
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800005200144Will3DWill3D2017-12-22
08800005200410DENTRI MaxDENTRIα2022-04-29
08800005200427DENTRI MaxDENTRI-Cα2022-04-29
08800005200434DENTRI MaxDENTRI-Sα2022-04-29
08800005200205eco-x serieseco-x-s2022-02-21
08800005200380DENTRIα seriesDENTRIα2022-02-09
08800005200397DENTRIα seriesDENTRI-Cα2022-02-09
08800005200403DENTRIα seriesDENTRI-Sα2022-02-09
08800005200021DENTRIα SeriesDENTRIα2016-12-25
08800005200038DENTRIα SeriesDENTRI-Cα2016-12-25
08800005200045DENTRIα SeriesDENTRI-Sα2016-12-16
08800005200113DENTIOIII seriesDENTIOIII2019-03-04
08800005200120DENTIOIII seriesDENTIOIII-S2019-03-04
08800005200168WillCephWillCeph2018-05-03
08800005200298Will3DWill3D2021-12-21
08800005200151STAR-XSTAR-X2021-04-28
08800005200175XcamXcam2021-04-28
08800005200182Real ArchReal Arch2021-01-04

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