Catalog Number

766089-STM

Brand Name

Ceramill® Zolid

Version/Model Number

ZOLID-HT+ preshade B3 16mm

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K171876

Product Code

EIH

Product Code Name

Powder, Porcelain

Public Device Record Key

6dca4b4a-aa10-4c1b-b334-3f925a9143f6

Public Version Date

November 30, 2020

Public Version Number

3

DI Record Publish Date

May 08, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-