Duns Number:315427286
Device Description: "Protection wax for relief from irritation caused by brackets and ligature wires.Form of "Protection wax for relief from irritation caused by brackets and ligature wires.Form of delivery: 50 boxes of 5 bars each"
Catalog Number
-
Brand Name
N.A.
Version/Model Number
124-305-00
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 12, 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
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
-
Product Code
EGD
Product Code Name
WAX, DENTAL, INTRAORAL
Public Device Record Key
0f85c814-e206-43fc-94d5-0b2e8b32ec54
Public Version Date
December 01, 2020
Public Version Number
3
DI Record Publish Date
September 15, 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 |