Catalog Number

005.017

Brand Name

CeraRoot Implant System

Version/Model Number

005.017

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)

-

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

32c43844-f169-40b9-85ea-7a809d6c223d

Public Version Date

September 23, 2019

Public Version Number

1

DI Record Publish Date

September 14, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-