Catalog Number

760554

Brand Name

Ceramill TEMP

Version/Model Number

Ceramill TEMP bleach 98x20 N/US

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"

-

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

K071548

Product Code

EBG

Product Code Name

Crown And Bridge, Temporary, Resin

Public Device Record Key

3314c14e-5b78-4c94-bf7f-04c23c1fc522

Public Version Date

December 13, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-