Catalog Number

-

Brand Name

Bone Level Fixture

Version/Model Number

PBF 5008S

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K190641

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

d123b6a4-f3f0-4c7d-bed9-2b4b39c342f6

Public Version Date

June 16, 2022

Public Version Number

1

DI Record Publish Date

June 08, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-