Duns Number:789664455
Device Description: Light Super Bond represents state-of- the-art technology: it offers the most desirable cha Light Super Bond represents state-of- the-art technology: it offers the most desirable characteristics, in versatility, ease of handling and reliability. • Unlimited working time-cures on demand with a visible light-curing unit.• Bracket compatibility-designed to be used with ceramic, plastic or metal brackets.• Viscosity-consistency of the Light Super Bond-M paste eliminates bracket flotation.• High light sensitivity of the material allows for the use of Light Super Bond-M not only for bonding translucent (plastic or ceramic) brackets, but also for light impermeable metal ones.• Light Super Bond-M is a light cured material, which allows for relief from time pressure.• The dentist, therefore, has plenty of time for cleaning the excess adhesive around the bracket bases. • Simplicity of application procedure, and relief from time pressure, results in obtaining reproducible bond strength, and precise bracket placement.• The material has superior resistance to discoloration. It is economical to use and has virtually no waste and long shelf life, all of which contribute to the ease of working with this product.
Catalog Number
1011
Brand Name
Light Super Bond-M-L/C Orthodontic Adhesive Single Syringe
Version/Model Number
1011
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"
Yes
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
-
Product Code
DYH
Product Code Name
Adhesive, Bracket And Tooth Conditioner, Resin
Public Device Record Key
5d75583b-1641-497f-ba33-591aa3b7233b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 03, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 59 |