HDX WILL CORP.

Address:#105,106,201,202,203,204,38,Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu,Cheongju-si, Chungcheongbuk-do Chungbuk,KR

Want to know more about this Organization? Request more information now!

Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

X-Ray, Tomography, Computed, Dental (OAS) (3) System, Image Processing, Radiological (LLZ) (2) System, X-Ray, Extraoral Source, Digital (MUH) (2) Unit, X-Ray, Extraoral With Timer (EHD) (2) System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations (NOF) (1)

Premarket Exempt

No Yes

Clear

DENTRIα Series - 08800005200021 Catalog Number :

Device Description : Device Description: DENTRIα Series is a dental CT, panoramic X-ray system, whic Device Description: DENTRIα Series is a dental CT, panoramic X-ray system, which is intended for dental radiographic examination and diagnosis of teeth, jaw and oral structures.

Device Class : 2

Duns Number: 689605054

Premarket Exempt : No

Product Code : OAS

Prescription Use : Yes

Device Count : 1

DENTRIα Series - 08800005200038 Catalog Number :

Device Description : Device Description: DENTRIα Series is a dental CT, panoramic, cephalometric X-r Device Description: DENTRIα Series is a dental CT, panoramic, cephalometric X-ray system, which is intended for dental radiographic examination and diagnosis of teeth, jaw and oral structures.

Device Class : 2

Duns Number: 689605054

Premarket Exempt : No

Product Code : OAS

Prescription Use : Yes

Device Count : 1

DENTRIα Series - 08800005200045 Catalog Number :

Device Description : Device Description: DENTRIα Series is a dental CT, panoramic, cephalometric X-ra Device Description: DENTRIα Series is a dental CT, panoramic, cephalometric X-ray system, which is intended for dental radiographic examination and diagnosis of teeth, jaw and oral structures.

Device Class : 2

Duns Number: 689605054

Premarket Exempt : No

Product Code : OAS

Prescription Use : Yes

Device Count : 1

DENTIOIII series - 08800005200113 Catalog Number :

Device Description : The DENTIOIII is intended for dental radiographic examination of the teeth and t 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.

Device Class : 2

Duns Number: 689605054

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

DENTIOIII series - 08800005200120 Catalog Number :

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

Device Class : 2

Duns Number: 689605054

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

Will3D - 08800005200144 Catalog Number :

Device Description : The Will3D is one of the components of a PACS (Picture Archiving and Communicati The Will3D is one of the components of a PACS (Picture Archiving and Communications System). The Will3D is the software application that provides image viewing and manipulation in the diagnostic imaging setting.

Device Class : 2

Duns Number: 689605054

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

STAR-X - 08800005200151 Catalog Number :

Device Description : Star-X is intra-oral X-ray system for dental diagnosis that can radiate X-ray im Star-X is intra-oral X-ray system for dental diagnosis that can radiate X-ray images by irradiating X-rays generated by high voltage to an anode in an X-ray tube and reacting with the receptor (film, sensor).Star-X is a dental X-ray equipment (extra-oral source system) intended for use by qualified dentist or dental technician for both adult and pediatric patient for producing diagnostic dental radiographs for treatment of diseases of the teeth, jaw, and other oral structures using intra-oral image receptors.

Device Class : 2

Duns Number: 689605054

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

WillCeph - 08800005200168 Catalog Number :

Device Description : WillCeph is intended for use by orthodontists, oral surgeons, and their clinical WillCeph is intended for use by orthodontists, oral surgeons, and their clinical staffs in storing and organizing images, including digitla photographs, x-rays, and others. The system includes the capability to trace a cephalometric x-ray, analyze the measurements taken, and make growth or surgical predictions

Device Class : 2

Duns Number: 689605054

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Xcam - 08800005200175 Catalog Number :

Device Description : This X-ray Unit is intended to be used in portable applications, by a qualified/ This X-ray Unit is intended to be used in portable applications, by a qualified/trained dentist or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of dental structures.

Device Class : 2

Duns Number: 689605054

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

Real Arch - 08800005200182 Catalog Number :

Device Description : Real Arch is a dental 3D scanner intended to be used to digitally record topogra 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.

Device Class : 2

Duns Number: 689605054

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

Previous 1 2 Next