Catalog Number

001.007

Brand Name

CeraRoot Implant System

Version/Model Number

001.007

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 14, 2019

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

NDP

Product Code Name

Accessories, Implant, Dental, Endosseous

Public Device Record Key

8368eb5d-1ae5-4eda-b90e-d7e61e56d9c7

Public Version Date

October 26, 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

-