Catalog Number

668004

Brand Name

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

Version/Model Number

668004

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

K041343,K041343,K041343

Product Code

KLE

Product Code Name

AGENT, TOOTH BONDING, RESIN

Public Device Record Key

5fcc0348-9f0e-445f-8d90-7e0f5d73fe7b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

D00266800462

Quantity per Package

6

Contains DI Package

D0026680041

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box