Catalog Number

Z50C

Brand Name

dental diamond bur

Version/Model Number

Z50C

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DZP

Product Code Name

Instrument, Diamond, Dental

Public Device Record Key

c2ad5fa3-34c5-4a4f-b1b6-1b8fff581cd8

Public Version Date

March 23, 2020

Public Version Number

3

DI Record Publish Date

February 13, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-