Catalog Number

MPI-10375

Brand Name

Ditron Dental

Version/Model Number

MPI-10375

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

Yes

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

K140728,K161497

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

710fbc28-c4cd-47c2-b054-700a9c7df7e2

Public Version Date

August 16, 2022

Public Version Number

5

DI Record Publish Date

September 11, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-