Catalog Number

001.004

Brand Name

CeraRoot Implant System

Version/Model Number

001.004

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

-

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

K093595

Product Code

DZI

Product Code Name

Drill, Bone, Powered

Public Device Record Key

9a2742dd-ed5b-4bc8-838c-cfa4959591d5

Public Version Date

January 09, 2020

Public Version Number

2

DI Record Publish Date

September 14, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-