Catalog Number

DD-1000

Brand Name

Defend

Version/Model Number

DD-1000

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K953504

Product Code

KLE

Product Code Name

Agent, Tooth Bonding, Resin

Public Device Record Key

2d03b763-b4f2-4d43-9517-9768320d7449

Public Version Date

September 27, 2022

Public Version Number

6

DI Record Publish Date

December 13, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-