Duns Number:687789453
Device Description: DiaTemp is a temporary filling material that sets with curing light. In case the cavity is DiaTemp is a temporary filling material that sets with curing light. In case the cavity is not permanentlyrestored, Diatemp can be used as a temporary restoration until the next appointment. DiaTemp hasfour models and packaged with syringe and protective cap.
Catalog Number
A2001-6950
Brand Name
DiaTemp
Version/Model Number
Intro kit Yellow 1g
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
K192158
Product Code
EBG
Product Code Name
Crown And Bridge, Temporary, Resin
Public Device Record Key
9a1ec7e2-e053-4bed-93be-496a81e1348d
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 |