Catalog Number

75001

Brand Name

Micro Esthetic A3

Version/Model Number

75001

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)

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

87f99cb0-172f-490c-881c-a0d8a64fe4e5

Public Version Date

June 29, 2020

Public Version Number

4

DI Record Publish Date

November 29, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-