Catalog Number

75104

Brand Name

Micro Esthetic 20 Compules B2

Version/Model Number

75104

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

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

K984484

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

c78d84ab-1d6d-4fe1-943f-42b078348bb8

Public Version Date

June 29, 2020

Public Version Number

4

DI Record Publish Date

December 04, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-