Catalog Number

70-1185-BXP0211

Brand Name

BruxZir Shaded 16 PLUS

Version/Model Number

70-1185-BXP0211

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

K130924

Product Code

EIH

Product Code Name

POWDER, PORCELAIN

Public Device Record Key

7b1a42b8-350b-4308-a2e0-b6e78fb4e119

Public Version Date

June 22, 2020

Public Version Number

1

DI Record Publish Date

June 12, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-