Duns Number:688322841
Device Description: MD-Cleanser is used to removal the inorganic and organic material as the root canal cleans MD-Cleanser is used to removal the inorganic and organic material as the root canal cleanser.
Catalog Number
-
Brand Name
MD-Cleanser
Version/Model Number
9208
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
EKQ
Product Code Name
Preparer, Root Canal Endodontic
Public Device Record Key
103a089e-0a6a-4fea-858f-125091612415
Public Version Date
October 03, 2022
Public Version Number
1
DI Record Publish Date
September 24, 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 | 1335 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 284 |