Duns Number:316699578
Device Description: V-Posil impression materials are addition-curing, elastomeric materials with high hydrophi V-Posil impression materials are addition-curing, elastomeric materials with high hydrophilic properties, high tear strength, high dimensional accuracy and a high resistance to permanent deformation.
Catalog Number
2985
Brand Name
V-Posil
Version/Model Number
2985
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
EID
Product Code Name
Syringe, Restorative And Impression Material
Public Device Record Key
5d27482f-d811-4dda-9f3e-7b7010faf405
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 03, 2017
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 | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 396 |
| U | Unclassified | 5 |