Duns Number:113170088
Device Description: Light Bond is intended for use as a light cure bracket and lingual retainer adhesive. Ligh Light Bond is intended for use as a light cure bracket and lingual retainer adhesive. Light Bond™ will bond to any enamel, porcelain, composite or metal surface, when properly conditioned.This kit contains 4 X 5g light cure paste in individual mixing tips, 2 X 3cc Light Bond Sealant, 1 X 23g etchant and mixing accessories. This kit does not contains fluoride.
Catalog Number
LBET
Brand Name
Light Bond
Version/Model Number
LBET
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 08, 2019
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
K895522
Product Code
DYH
Product Code Name
Adhesive, Bracket And Tooth Conditioner, Resin
Public Device Record Key
b8306911-c6ef-4fae-bfbe-727a3bc0660d
Public Version Date
May 09, 2019
Public Version Number
2
DI Record Publish Date
September 24, 2018
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 |