Duns Number:078444642
Device Description: Jade Blue 37% Phosphoric Acid Etchant Gel Kit - 25 x 1.2ml Syringes, 50 Pre-bent 23ga Tips Jade Blue 37% Phosphoric Acid Etchant Gel Kit - 25 x 1.2ml Syringes, 50 Pre-bent 23ga Tips & Instruction Insert
Catalog Number
20-00004
Brand Name
Jade
Version/Model Number
20-00004
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,K150696
Product Code
KLE
Product Code Name
Agent, Tooth Bonding, Resin
Public Device Record Key
9099f5cb-8a96-430b-b2c9-fb29374708cd
Public Version Date
March 11, 2019
Public Version Number
3
DI Record Publish Date
October 07, 2016
Package DI Number
10353045000656
Quantity per Package
30
Contains DI Package
00353045000659
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 |