Catalog Number

-

Brand Name

OsseoFuse HexaPlus Sinus Dental Implant

Version/Model Number

SLF4513

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 05, 2020

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

-

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

ba1f66f5-8270-4f35-aee3-b5575f9ac61f

Public Version Date

March 05, 2020

Public Version Number

3

DI Record Publish Date

January 22, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-