Catalog Number

-

Brand Name

DentiMax

Version/Model Number

Dream Sensor Size 2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

September 19, 2025

Issuing Agency

In GS1

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

K092547

Product Code

MUJ

Product Code Name

System,Planning,Radiation Therapy Treatment

Public Device Record Key

ea8d461f-55a3-4207-b290-629636eba602

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-