Catalog Number

SSSA 45304

Brand Name

UF(II) Implant System

Version/Model Number

SSSA 45304

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 28, 2022

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

K170608

Product Code

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Public Device Record Key

e955d171-d245-42e9-a6fb-b9b423d34de4

Public Version Date

February 28, 2022

Public Version Number

4

DI Record Publish Date

August 24, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-