Duns Number:001006089
Device Description: Medium Viscosity Automix Syringe Kit: 7 gm cement, 20 automix tips, 1.2 mL each Seal-n-Shi Medium Viscosity Automix Syringe Kit: 7 gm cement, 20 automix tips, 1.2 mL each Seal-n-Shine and OxOut, accessoriesDual Cure, Fluoride Releasing, Radiopaque
Catalog Number
-
Brand Name
EMBRACE WETBOND RESIN CEMENT
Version/Model Number
EMCM
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 01, 2020
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
EMA
Product Code Name
Cement, Dental
Public Device Record Key
53ea7a97-ab71-41f0-8900-ba4d587146af
Public Version Date
January 01, 2020
Public Version Number
4
DI Record Publish Date
July 28, 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 | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 177 |