Duns Number:036623932
Device Description: 12x1.2ml Syringe 40% Phosphoric Acid Etch Gel
Catalog Number
-
Brand Name
Velvet Etch
Version/Model Number
503300
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
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
KLE
Product Code Name
Agent, Tooth Bonding, Resin
Public Device Record Key
3d2ebaf0-f87e-480c-982d-ebb05152c0de
Public Version Date
May 21, 2021
Public Version Number
1
DI Record Publish Date
May 13, 2021
Package DI Number
40818207020879
Quantity per Package
20
Contains DI Package
30818207020872
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 316 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 144 |
| U | Unclassified | 36 |