Duns Number:046513054
Device Description: Fluoride containing dentin cleaning agent to desensitize and clean a prepared tooth prior Fluoride containing dentin cleaning agent to desensitize and clean a prepared tooth prior to placement of an amalgam restoration or placement of a crown &/or bridge.
Catalog Number
HG10010
Brand Name
HEMA-BENZ
Version/Model Number
HG10010
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
a238fb62-db30-4017-8356-86c9a014121f
Public Version Date
February 07, 2019
Public Version Number
3
DI Record Publish Date
July 11, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |