Catalog Number

-

Brand Name

Standard Plus Implant

Version/Model Number

011010

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 05, 2018

Issuing Agency

In GS1

MRI safety Status

MR Safe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

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

K150388

Product Code

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Public Device Record Key

18e0e270-dc3e-4991-9196-bf97e847f794

Public Version Date

July 09, 2020

Public Version Number

5

DI Record Publish Date

June 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-