Catalog Number

760269

Brand Name

Ceramill® Zolid

Version/Model Number

Zolid PS 2 98x16 N

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 08, 2021

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"

Yes

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

K063511

Product Code

EIH

Product Code Name

Powder, Porcelain

Public Device Record Key

649a8851-7d3d-4fbb-9f4a-df3ca200941c

Public Version Date

May 10, 2021

Public Version Number

5

DI Record Publish Date

June 30, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-