Duns Number:124763728
Device Description: The TempoLok™ Automix NE refill includes: one double cartridge (118 g) non-eugenol, zinc o The TempoLok™ Automix NE refill includes: one double cartridge (118 g) non-eugenol, zinc oxide cement and 50 mixing tips. This product is used for 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.
Catalog Number
-
Brand Name
TempoLok NE Cement 118g cartridge, 50 mixing tips
Version/Model Number
220282
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 02, 2022
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
3269aff1-f8b4-42e4-a613-0bbcb2877f0a
Public Version Date
March 04, 2022
Public Version Number
5
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 |