Catalog Number

EXPERTDC55 NA

Brand Name

Gendex eXpert DC™ intraoral x-ray system

Version/Model Number

0.822.5212

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K992610

Product Code

EHD

Product Code Name

UNIT, X-RAY, EXTRAORAL WITH TIMER

Public Device Record Key

519fc68c-4eb2-426d-8668-0d51d28a53e0

Public Version Date

January 31, 2022

Public Version Number

5

DI Record Publish Date

September 27, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-