Duns Number:113170088
Device Description: Quick Cure is intended for use as a light cure bracket adhesive. This Quick Cure kit conta Quick Cure is intended for use as a light cure bracket adhesive. This Quick Cure kit contains 4 X 5g Quick Cure Paste in push Syringes, 1 X 6cc Assure Plus Bonding Resin, 1 X 23g Etchant and mixing accessories Contains fluoride
Catalog Number
QCPPLUS
Brand Name
Quick Cure
Version/Model Number
QCPPLUS
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 04, 2016
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
-
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
DYH
Product Code Name
Adhesive, Bracket And Tooth Conditioner, Resin
Public Device Record Key
06b2c1a9-d7a1-481a-8389-73841606eaaa
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 17, 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 | 73 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 279 |