Duns Number:388000846
Device Description: For the adhesion between impression tray and silicone impression material, high adhesion a For the adhesion between impression tray and silicone impression material, high adhesion and still easy cleaning of the tray.20 ml bottle with brush insert for prefabricated metal or plastic trays. Colour: red.
Catalog Number
D5114
Brand Name
Fresh adhäsiv
Version/Model Number
1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 09, 2018
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K053427
Product Code
ELW
Product Code Name
Material, Impression
Public Device Record Key
16ea9dad-4b5c-4bd7-ab22-ac76eb63bb5c
Public Version Date
April 09, 2019
Public Version Number
4
DI Record Publish Date
October 07, 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 | 129 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 45 |