Duns Number:113170088
Device Description: Light Bond is intended for use as a light cure bracket and lingual retainer adhesive. Lig 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 the 20g medium viscosity adhesive paste in tips, 2 X 3cc Light Bond Sealant, 1 X 23g liquid etchant and mixing accessories. This product contains fluoride.
Catalog Number
LBEMTF
Brand Name
Light Bond
Version/Model Number
LBEMTF
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
KLE
Product Code Name
Agent, Tooth Bonding, Resin
Public Device Record Key
8ce54b93-7145-4790-8221-1cf5a2a23403
Public Version Date
May 09, 2019
Public Version Number
4
DI Record Publish Date
August 08, 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 |