Catalog Number

PITI-6.0-8.0 (30°) PS+1.5

Brand Name

Tatum Surgical-Integrity Platform Switching Abutment 6.0-8.0, 30°

Version/Model Number

PITI-6.0-8.0 (30°) PS+1.5

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 08, 2021

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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

7ecb04d0-ba6b-4dca-ae39-ffa540ad519f

Public Version Date

April 09, 2021

Public Version Number

2

DI Record Publish Date

October 09, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-