Catalog Number

668005

Brand Name

Xeno® IV One Component Light Cured Self-Etching Dental Adhesive

Version/Model Number

668005

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 28, 2019

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K041343

Product Code

KLE

Product Code Name

AGENT, TOOTH BONDING, RESIN

Public Device Record Key

5d6c7ec4-2408-4e83-9a17-5cc12a9ed0be

Public Version Date

October 03, 2022

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-