Catalog Number

0886

Brand Name

MiYO Esthetic System

Version/Model Number

MiYO Gingival Sorbet Paste 4g

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K111743

Product Code

EIH

Product Code Name

Powder, Porcelain

Public Device Record Key

bb2afcc4-aca4-4480-8e64-3ef2ba1f49a0

Public Version Date

January 14, 2020

Public Version Number

2

DI Record Publish Date

December 11, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-