Catalog Number

C-5212

Brand Name

eCement

Version/Model Number

C-5212

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

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

bbcdb4e2-df70-4c66-9063-70d780c4d6ec

Public Version Date

October 18, 2022

Public Version Number

1

DI Record Publish Date

October 10, 2022

Package DI Number

10810111542262

Quantity per Package

1

Contains DI Package

00810111542265

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Item No: C-52120P