Duns Number:124763728
Device Description: A temporary crown and bridge material refill for temporary crowns and bridges, long term t A temporary crown and bridge material refill for temporary crowns and bridges, long term temporaries and provisional inlays, onlays, and veneers.
Catalog Number
-
Brand Name
InstaTemp® Max Temp. Material A3.5 76g cart., 15 mixing tips
Version/Model Number
220219
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
K013674
Product Code
EBG
Product Code Name
Crown And Bridge, Temporary, Resin
Public Device Record Key
19a85cc6-6ab8-4fcb-99ac-ee9728f6be27
Public Version Date
May 28, 2020
Public Version Number
4
DI Record Publish Date
February 20, 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 |