Duns Number:315427286
Device Description: "Stains Universal Set / Contents: Stains universal set15 Stains universal / 1 Stains unive "Stains Universal Set / Contents: Stains universal set15 Stains universal / 1 Stains universal liquid / 1 Shade guide for stains universal"
Catalog Number
-
Brand Name
N.A.
Version/Model Number
296-000-01
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 02, 2018
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
Yes
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
K011425
Product Code
EIH
Product Code Name
POWDER, PORCELAIN
Public Device Record Key
4bb0ac79-0bb6-4ef1-b736-67407ad8012e
Public Version Date
October 02, 2018
Public Version Number
5
DI Record Publish Date
November 23, 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 | 2768 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1745 |