Catalog Number

-

Brand Name

DEXIS Titanium Intraoral X-Ray Sensor

Version/Model Number

1.012.6180

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 11, 2022

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K172918

Product Code

MUH

Product Code Name

System, X-Ray, Extraoral Source, Digital

Public Device Record Key

bd250b2f-4f7b-4460-8496-1a1ed5eb9a64

Public Version Date

August 30, 2022

Public Version Number

6

DI Record Publish Date

January 21, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-