Catalog Number

6029M

Brand Name

3M™ ESPE™ Filtek™ Supreme Ultra Universal Restorative

Version/Model Number

6029M

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

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

a9e4d0b7-0253-4090-9e3f-b0bb7ab73356

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 13, 2017

Package DI Number

50605861012015

Quantity per Package

10

Contains DI Package

30605861012011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX