Duns Number:243750762
Device Description: 2 x 50 ml EasySoft Liner1 x 50 ml EasySoft Liner Sealant1 x 10 ml EasySoft Liner Adhesive( 2 x 50 ml EasySoft Liner1 x 50 ml EasySoft Liner Sealant1 x 10 ml EasySoft Liner Adhesive(mixing tips, brushes, polishing discs and mandrel are all used outside of mouth and are not medical devices)
Catalog Number
-
Brand Name
EasySoft Liner Starter Kit
Version/Model Number
0501
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EBI
Product Code Name
Resin, Denture, Relining, Repairing, Rebasing
Public Device Record Key
3950272a-9c52-481f-812f-45538476205b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 08, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |