Duns Number:830016148
Device Description: 3M™ ESPE™ Filtek™ Supreme Ultra Universal and Flowable Restoratives, 6029PP
Catalog Number
6029PP
Brand Name
Filtek™
Version/Model Number
6029PP
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
fae6e11b-5fb8-4675-93a1-d058746736b5
Public Version Date
August 21, 2019
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
50605861012930
Quantity per Package
10
Contains DI Package
30605861012936
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 444 |
| U | Unclassified | 7 |