Duns Number:898067533
Device Description: Ambar APS is a light-curing 5th generation adhesive (two-step adhesive, total etch techniq Ambar APS is a light-curing 5th generation adhesive (two-step adhesive, total etch technique) for bonding restorative materials to dental tissue (enamel and/ or dentin).
Catalog Number
4000019358
Brand Name
Ambar APS
Version/Model Number
6mL
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
-
Product Code
KLE
Product Code Name
Agent, Tooth Bonding, Resin
Public Device Record Key
17f454cf-e7a7-4c6b-881d-9192c1ad6ee9
Public Version Date
November 08, 2021
Public Version Number
3
DI Record Publish Date
January 31, 2020
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 | 12 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 99 |