Duns Number:078444642
Device Description: Jade Green 37% Phosphoric Acid Etchant Gel - 1 x 10ml Syringe, 20 Pre-bent 23ga Tips & Ins Jade Green 37% Phosphoric Acid Etchant Gel - 1 x 10ml Syringe, 20 Pre-bent 23ga Tips & Instruction Insert
Catalog Number
20-00007
Brand Name
Jade
Version/Model Number
20-00007
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K150696,K150696
Product Code
KLE
Product Code Name
Agent, Tooth Bonding, Resin
Public Device Record Key
0d882b0d-d1fc-4d63-a1ce-dcb433cf11d4
Public Version Date
March 11, 2019
Public Version Number
3
DI Record Publish Date
October 07, 2016
Package DI Number
10353045000687
Quantity per Package
48
Contains DI Package
00353045000680
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |