Duns Number:002287223
Device Description: A thermoplastic material designed to reproduce the structure of a patient's teeth and gums A thermoplastic material designed to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. It is composed of a mixture of natural resins, fillers, and lubricants. This is a single-use device.
Catalog Number
-
Brand Name
TEMP TABS NATURAL
Version/Model Number
143033
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
EBG
Product Code Name
Crown And Bridge, Temporary, Resin
Public Device Record Key
d4d2431e-a653-43d9-a9d3-c68eb2c158a2
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 20, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |