Catalog Number

28434S

Brand Name

Visalys Veneer

Version/Model Number

28434S

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 07, 2022

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

Yes

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

K982692

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

59e0ef15-b1c8-4516-aa67-656d0537f911

Public Version Date

March 08, 2022

Public Version Number

4

DI Record Publish Date

September 19, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-