Catalog Number

PITI-2.0 AS

Brand Name

TatumSurgical/Integrity 2.0mm Abutment RH Screw for 3.7-5.0mm Implants

Version/Model Number

2.0 RH Integrity Abutment Screw

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

39204ada-3fb5-4ec3-9c46-e55ca2eaa3d3

Public Version Date

June 18, 2021

Public Version Number

5

DI Record Publish Date

August 24, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-