Catalog Number

PITI3.7-4.5 Blank

Brand Name

Tatum Surgical/Abutment (Post)

Version/Model Number

Abutment/3.7 to 4.5 Blank straight post for Integrity 3.7-4.5 Implants

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 01, 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

5ddabf6f-bed0-4869-9a17-6964f6cc6ff5

Public Version Date

June 02, 2020

Public Version Number

2

DI Record Publish Date

June 08, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-