DENTRIα Series - Device Description: DENTRIα Series is a dental - HDX WILL CORP.

Duns Number:689605054

Device Description: Device Description: DENTRIα Series is a dental CT, panoramic, cephalometric X-ray system, 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.

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


More Product Details

Catalog Number

-

Brand Name

DENTRIα Series

Version/Model Number

DENTRI-Cα

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K160140

Product Code Details

Product Code

OAS

Product Code Name

X-Ray, Tomography, Computed, Dental

Device Record Status

Public Device Record Key

2c7e9f9b-6907-4480-b78a-03733e3be39e

Public Version Date

January 06, 2022

Public Version Number

4

DI Record Publish Date

December 25, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HDX WILL CORP." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 19