Duns Number:013369913
Device Description: PermaShade LC Light Cure Veneer Cement Refill - Opaque White
Catalog Number
5228
Brand Name
PermaShade LC
Version/Model Number
5228
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
K111836
Product Code
EMA
Product Code Name
CEMENT, DENTAL
Public Device Record Key
8daa917e-ab18-465c-93b7-c9ad266baea0
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 22, 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 | 450 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 631 |
| U | Unclassified | 18 |