Duns Number:687789453
Device Description: DIA-KONDENSOR is having both a nIckel-titanium end a stainless steel end, it can be used i DIA-KONDENSOR is having both a nIckel-titanium end a stainless steel end, it can be used in any common endodontic obturation technique including warm and cold condensation.
Catalog Number
551-101
Brand Name
DIA-KONDENSOR
Version/Model Number
#35/70
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
DZA
Product Code Name
Drill, Dental, Intraoral
Public Device Record Key
d0a76a56-f503-4e52-a60e-3be98f3cc3e5
Public Version Date
June 04, 2020
Public Version Number
1
DI Record Publish Date
May 27, 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 |