Duns Number:001006089
Device Description: 3 mL syringe- Calcium hydroxide canal treatment paste, radiopaque
Catalog Number
-
Brand Name
TEMPCANAL™
Version/Model Number
PTC
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 01, 2016
Issuing Agency
In HIBCC
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
EJK
Product Code Name
Liner, Cavity, Calcium Hydroxide
Public Device Record Key
d65e9255-1c23-40e1-912e-d3ab21901fe0
Public Version Date
November 26, 2019
Public Version Number
3
DI Record Publish Date
September 08, 2016
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 | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 177 |