Duns Number:316699578
Device Description: Dimanto is a one-step polishing system for pre-polishing and highglosspolishing finished c Dimanto is a one-step polishing system for pre-polishing and highglosspolishing finished composite restorations. The diamondinterspersedsilicone polishers are suitable for repeated use.
Catalog Number
2385
Brand Name
Dimanto
Version/Model Number
2385
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EHJ
Product Code Name
Disk, Abrasive
Public Device Record Key
f2c7bf0c-b8ce-4be9-9974-ecc154c4b8dc
Public Version Date
March 23, 2020
Public Version Number
3
DI Record Publish Date
June 06, 2019
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 | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 396 |
| U | Unclassified | 5 |