Duns Number:529607549
Device Description: Used for zirconia coloring of our all - porcelain denture
Catalog Number
-
Brand Name
Aidite
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
EIH
Product Code Name
Powder, Porcelain
Public Device Record Key
a1b752f9-39c0-4f64-85b0-7a0aa0ba9586
Public Version Date
March 31, 2022
Public Version Number
1
DI Record Publish Date
March 23, 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 |