Duns Number:102422578
Device Description: 1-Step Silane primer applied to porcelain dental restorations for bonding to teeth.
Catalog Number
006-00078
Brand Name
FastFix Porcelain Primer Kit
Version/Model Number
006-00078
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
-
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
K091300,K091300
Product Code
KLE
Product Code Name
Agent, Tooth Bonding, Resin
Public Device Record Key
399da63d-3fbd-4eb0-b168-370b1e908766
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 10, 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 | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 51 |