Catalog Number

0100

Brand Name

Profiling Bur for ISI/TSI/ERI

Version/Model Number

5mm Profiling Bur

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DZN

Product Code Name

Instruments, Dental Hand

Public Device Record Key

c6c82f82-29a8-40c6-8178-c74e8bbaa845

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

April 28, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-