Catalog Number

75102

Brand Name

Micro Esthetic 20 Compules A3.5

Version/Model Number

75102

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

fcae8d94-8d73-41ca-95df-f8a75301f9db

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

-