Catalog Number

-

Brand Name

Luminesse Low Fusing Dentin Powder

Version/Model Number

1902A0

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K140848

Product Code

EIH

Product Code Name

Powder, Porcelain

Public Device Record Key

2c28a216-54bf-42e1-80d4-6dce2c7b7c79

Public Version Date

July 24, 2018

Public Version Number

4

DI Record Publish Date

October 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-