Duns Number:067488114
Device Description: Paste used to etch the surface of porcelain to help create a greater surface area and a st Paste used to etch the surface of porcelain to help create a greater surface area and a stronger retention for bonding.
Catalog Number
06-4000
Brand Name
Porcelain Etching Paste
Version/Model Number
15 mL
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EBO
Product Code Name
Denture Repair Kit
Public Device Record Key
e80339bb-2d30-4209-badf-3ca1adc5aaa1
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 05, 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 | 28 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 130 |