Catalog Number

638246WW

Brand Name

Tetric EvoCeram Bulk Fill

Version/Model Number

638246WW

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 24, 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"

-

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

EBF

Product Code Name

MATERIAL, TOOTH SHADE, RESIN

Public Device Record Key

fb2594fb-8fe6-4bad-b07a-9bb2e3ac2215

Public Version Date

June 25, 2021

Public Version Number

3

DI Record Publish Date

November 11, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-