Catalog Number

036PTN10

Brand Name

ENDODONTIC POSTS

Version/Model Number

TITANIUM PIVOTS KIT STD./size mm.10 pz.5

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 27, 2021

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

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

-

Product Code

ELR

Product Code Name

Post, Root Canal

Public Device Record Key

aeb045bc-a95e-42d1-ac44-0dbc0590e858

Public Version Date

January 28, 2021

Public Version Number

2

DI Record Publish Date

January 05, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-