Duns Number:053529939
Device Description: Universal Primer Part A 6ml Bottle
Catalog Number
B-4101
Brand Name
Universal Primer
Version/Model Number
B-4101
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 12, 2022
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
K131734
Product Code
KLE
Product Code Name
AGENT, TOOTH BONDING, RESIN
Public Device Record Key
53c9690c-12a3-400f-9c69-1fdf558414b6
Public Version Date
October 13, 2022
Public Version Number
5
DI Record Publish Date
June 12, 2017
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 | 335 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 675 |