Catalog Number

PN50.60

Brand Name

TatumSurgical/Abutment (Post)

Version/Model Number

Abutment/5.0mm x 60 degree Post

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 27, 2021

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

f03e42ab-e9cf-4fa9-814c-e8924570219b

Public Version Date

January 28, 2021

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

-