Duns Number:689370711
Device Description: Light-cured base/liner containing calcium hydroxyapatite in urethane methacrylate oligomer Light-cured base/liner containing calcium hydroxyapatite in urethane methacrylate oligomer.
Catalog Number
101-0101
Brand Name
Base It
Version/Model Number
101-0101
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EJK
Product Code Name
Liner, Cavity, Calcium Hydroxide
Public Device Record Key
7f7359e6-caa3-475d-9f98-0581aa0e0017
Public Version Date
September 08, 2022
Public Version Number
6
DI Record Publish Date
February 20, 2017
Package DI Number
20200106170421
Quantity per Package
20
Contains DI Package
08809262954524
Package Discontinue Date
January 25, 2021
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |