Duns Number:687789453
Device Description: Spreaders are used for lateral condensation of root canal fillings.
Catalog Number
520-206
Brand Name
SPREADERS
Version/Model Number
25m/m 30
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
EKK
Product Code Name
Spreader, Pulp Canal Filling Material, Endodontic
Public Device Record Key
d8ad4f38-0316-4b9f-b0ea-c87b633de2bf
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
June 17, 2020
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 | 4806 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 158 |