Duns Number:687789453
Device Description: DiaTemp Flow is a temporary fililng material that sets with curing light. In case that the DiaTemp Flow is a temporary fililng material that sets with curing light. In case that the cavity is notpermanently restored, DiaTemp Flow can be used as a temporary restoration until the next appointment.DiaTemp Flow has four models and packaged with the syringe, disposable tip, protective cap.
Catalog Number
A2003-2201
Brand Name
DiaTemp Flow
Version/Model Number
Yellow 1.8g
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
K192022
Product Code
EBG
Product Code Name
Crown And Bridge, Temporary, Resin
Public Device Record Key
4b11d8de-e5bf-4ebe-87c0-ba14bf111fec
Public Version Date
October 29, 2021
Public Version Number
2
DI Record Publish Date
February 25, 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 |