Catalog Number

-

Brand Name

EMBRACE ESTHETIC OPAQUERS

Version/Model Number

EMO5

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 01, 2020

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)

Yes

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

K031877

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

58d8dafb-d9b5-4c4e-8f68-bfaa0eda9182

Public Version Date

January 01, 2020

Public Version Number

2

DI Record Publish Date

November 22, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-