HDX WILL CORP.

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

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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 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 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 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

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

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

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

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

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/

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

Device Class : 2

Duns Number: 689605054

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

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