Catalog Number

HE41600

Brand Name

NBB External Hex

Version/Model Number

4.1 Temp Abutment

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

-

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

K915375

Product Code

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Public Device Record Key

5808d5b2-0d45-4dbd-8a44-6451874005d1

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

April 26, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-