Catalog Number

D-Tube

Brand Name

Ditron Dental

Version/Model Number

D-Tube

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

OFY

Product Code Name

Dental Implant Surgical Tray

Public Device Record Key

2f35652b-7f82-4c32-bab1-7b8eb9d8f827

Public Version Date

August 03, 2022

Public Version Number

3

DI Record Publish Date

May 30, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-