Duns Number:898067533
Device Description: Diamond Excel is a polishing paste produced using micronized diamonds with a very fine gri Diamond Excel is a polishing paste produced using micronized diamonds with a very fine grit (2 to 4 microns) and extremely hard in order to meet the requirements of polishing and shining porcelain, dental enamel, resins and other restoring materials. It can be used in prosthetic laboratories too.
Catalog Number
4000002091
Brand Name
Diamond
Version/Model Number
Excel
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EJR
Product Code Name
Agent, Polishing, Abrasive, Oral Cavity
Public Device Record Key
15621cf1-c0a4-4942-95fc-2f8952b2533d
Public Version Date
June 09, 2022
Public Version Number
1
DI Record Publish Date
June 01, 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 | 12 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 99 |