Catalog Number

001-900

Brand Name

No Mix30

Version/Model Number

001-900

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 31, 2022

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

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

K893037

Product Code

DYH

Product Code Name

ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN

Public Device Record Key

3ed8b945-5ad9-465d-9b20-140532e5a879

Public Version Date

February 01, 2022

Public Version Number

5

DI Record Publish Date

November 09, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-