Duns Number:124763728
Device Description: Temporary cement for attaching all kinds of temporaries, e.g. temporary crowns and bridges Temporary cement for attaching all kinds of temporaries, e.g. temporary crowns and bridges and inlays. They can also be used as a securely sealing protective cover for preparations to be restored later. The TempoLok™ NE includes: 2- 5ml Syringes and 20 Mixing Tips of non-eugenol, zinc oxide cement.
Catalog Number
-
Brand Name
TempoLok NE Cement 2x5ml syringe, 20 mixing tips
Version/Model Number
220265
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
Yes
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
K984340
Product Code
EMA
Product Code Name
Cement, Dental
Public Device Record Key
8350e3d3-3e9e-4565-b8c5-4d05460d201a
Public Version Date
January 09, 2020
Public Version Number
4
DI Record Publish Date
February 24, 2017
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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1346 |