Duns Number:315731711
Device Description: 3M™ ESPE™ Impregum™ Penta™ Heavy Body/Light Body Quick Step Polyether Impression Material 3M™ ESPE™ Impregum™ Penta™ Heavy Body/Light Body Quick Step Polyether Impression Material Intro Kit, P31779
Catalog Number
P31779
Brand Name
Impregum™ Penta™ Soft Quick Step Heavy Body
Version/Model Number
P31779
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EBH
Product Code Name
MATERIAL, IMPRESSION TRAY, RESIN
Public Device Record Key
057dd994-4eda-4080-a5a8-1270764da615
Public Version Date
September 22, 2020
Public Version Number
7
DI Record Publish Date
September 24, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 232 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 563 |
| U | Unclassified | 3 |