Catalog Number

20-00091

Brand Name

Jade

Version/Model Number

20-00091

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

K150696,K150696

Product Code

KLE

Product Code Name

Agent, Tooth Bonding, Resin

Public Device Record Key

e8dacf92-49db-4a27-a8b0-84d21bde262f

Public Version Date

March 11, 2019

Public Version Number

3

DI Record Publish Date

October 07, 2016

Package DI Number

10353045002131

Quantity per Package

25

Contains DI Package

00353045002134

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case