Catalog Number

PITI-40.15

Brand Name

TatumSurgical/Abutment (Integrity Post)

Version/Model Number

Abutment/4.0mm x 15 degree Integrity Post

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 17, 2020

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K811923

Product Code

DZE

Product Code Name

IMPLANT, ENDOSSEOUS, ROOT-FORM

Public Device Record Key

a63ee702-1850-4bb7-ba5a-5f71ad0affec

Public Version Date

November 18, 2020

Public Version Number

4

DI Record Publish Date

October 30, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-