Duns Number:009831413
Device Description: Quala Etch Gel Econo Kit 12-1.2ML Gel 50 Tips
Catalog Number
Q40012
Brand Name
Quala
Version/Model Number
Q40012
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 25, 2017
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
K941899,K941899
Product Code
KLE
Product Code Name
Agent, Tooth Bonding, Resin
Public Device Record Key
3ce84ce3-5dfb-4322-adf2-0e1a82673b97
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 13, 2017
Package DI Number
D023Q4001239
Quantity per Package
10
Contains DI Package
D23Q4001217
Package Discontinue Date
April 25, 2017
Package Status
Not in Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 224 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 192 |