Catalog Number

D4300

Brand Name

BioBleach® soft

Version/Model Number

D4300

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

-

Product Code

KMY

Product Code Name

POSITIONER, TOOTH, PREFORMED

Public Device Record Key

014b5ffd-ad8b-4d1c-81c9-e96080e0f187

Public Version Date

August 29, 2022

Public Version Number

1

DI Record Publish Date

August 19, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-