Catalog Number

626405

Brand Name

IPS e.max CAD

Version/Model Number

626405

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 01, 2022

Issuing Agency

In HIBCC

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

-

Product Code

EIH

Product Code Name

POWDER, PORCELAIN

Public Device Record Key

24a6f455-50b0-4ac6-82a7-71cacd133643

Public Version Date

February 02, 2022

Public Version Number

2

DI Record Publish Date

June 16, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-