Catalog Number

ERUD3

Brand Name

Ena HRI ®

Version/Model Number

ERUD3

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

K062906

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

fa4afa62-bb1a-400d-ac47-d1f32886763e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 05, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-