Catalog Number

EV32115

Brand Name

JDEvolution S

Version/Model Number

JDEvolution S dental implant D 3.25 L 11.5

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K143142

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

6b86bd8e-1e81-4b8a-ae0d-ea08b312558d

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

May 31, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-