Catalog Number

PITI-6.0-8.0 (0°)

Brand Name

Tatum Surgical Integrity Abutment

Version/Model Number

Abutment 6.0 - 8.0mm x 0° (Straight) Integrity Post

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Public Device Record Key

ebae820c-aee7-41c7-9f0c-73a799ba9530

Public Version Date

June 21, 2021

Public Version Number

2

DI Record Publish Date

November 17, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-