Catalog Number

DB3.5

Brand Name

ExHex

Version/Model Number

DB3.5

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 26, 2019

Issuing Agency

In HIBCC

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"

Yes

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

-

Product Code

NHA

Product Code Name

ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Public Device Record Key

aa496e2e-4d62-45a5-bf19-0ab1ace88943

Public Version Date

April 07, 2021

Public Version Number

6

DI Record Publish Date

February 11, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-