Duns Number:001804074
Device Description: Resin Cement Kit containing Part A (10g), Part B (10g), Neo-Seal Dentin Sealant (15ml), Re Resin Cement Kit containing Part A (10g), Part B (10g), Neo-Seal Dentin Sealant (15ml), Releasing Agent (1.5g)
Catalog Number
052200-000
Brand Name
Waterpik Neo-Temp Temporary Resin Cement
Version/Model Number
052200-000
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EMA
Product Code Name
Cement, Dental
Public Device Record Key
f1fece42-3484-4506-9603-cf6737f4fd47
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 29, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 293 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 56 |