Duns Number:529607549
Device Description: Used to stabilize ceramic restorations placed directly on the sintering tray or sintered n Used to stabilize ceramic restorations placed directly on the sintering tray or sintered nails during porcelain baking or glazing, and to protect ceramic restorations placed on sintered nails during firing
Catalog Number
-
Brand Name
Aidite Firing Paste
Version/Model Number
Aidite
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EJS
Product Code Name
Alloy, Other Noble Metal
Public Device Record Key
265afc78-df11-4fe5-bb90-a6e41184906e
Public Version Date
April 15, 2022
Public Version Number
1
DI Record Publish Date
April 07, 2022
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 | 414 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1198 |