Duns Number:315471722
Device Description: Prime&Bond active Standard Refill universal adhesive is a combined Etch&Rinse (Total Etch) Prime&Bond active Standard Refill universal adhesive is a combined Etch&Rinse (Total Etch), Self Etch and Selective Etch adhesive. It offers a simple adhesive application technique for both direct and indirect indications and bonds to enamel, dentin, composites, zirconia and metals.
Catalog Number
60667341
Brand Name
Prime&Bond active
Version/Model Number
60667341
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
KLE
Product Code Name
AGENT, TOOTH BONDING, RESIN
Public Device Record Key
198005ff-4734-4ebb-b572-a3fb0f012f7c
Public Version Date
December 17, 2018
Public Version Number
1
DI Record Publish Date
November 15, 2018
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |