Duns Number:341086190
Device Description: K-Primer ceramic primer, bonding agent, composite bonding 3 ml dropper bottle
Catalog Number
APK25003
Brand Name
K-Primer
Version/Model Number
APK25003
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EBI
Product Code Name
RESIN, DENTURE, RELINING, REPAIRING, REBASING
Public Device Record Key
b971b8cc-f889-43d9-b06d-8d1d5cf39628
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 20, 2016
Package DI Number
EBREAPK250039
Quantity per Package
1
Contains DI Package
EBREAPK250030
Package Discontinue Date
September 20, 2016
Package Status
Not in Commercial Distribution
Package Type
dummy
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 375 |