Duns Number:096010525
Device Description: Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Acti Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Activator / Primer Plastic Bottle. Non-Boxed.
Catalog Number
65-126
Brand Name
SciPharm Cure-On Touch Orthodontic Adhesive
Version/Model Number
SP 65-126
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K791132
Product Code
DYH
Product Code Name
Adhesive, Bracket And Tooth Conditioner, Resin
Public Device Record Key
021d4b23-8915-46a8-8f3d-8ac24d015936
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 10, 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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 476 |