Catalog Number

-

Brand Name

KONTACT

Version/Model Number

KPSTA150501

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K210220

Product Code

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Public Device Record Key

33dbde76-410a-4f59-a2a5-b96199980629

Public Version Date

December 09, 2021

Public Version Number

1

DI Record Publish Date

December 01, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-