Duns Number:113170088
Device Description: L.C.R™is a flowable, light cure orthodontic adhesive intended to be used within an orthodo L.C.R™is a flowable, light cure orthodontic adhesive intended to be used within an orthodontic, dental or pediatric dental office for the bonding of lingual retainers, creation of occlusal buildups and for retention of thermoplastic aligners. This kit contains 4 X 5g LCR Adhesive paste in push syringes, 2 X 3cc Light Bond Sealant, 1 X 23g Etchant and mixing accessories.
Catalog Number
LCREP
Brand Name
Light Bond
Version/Model Number
LCREP
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
-
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
K894564
Product Code
EBI
Product Code Name
Resin, Denture, Relining, Repairing, Rebasing
Public Device Record Key
701e196a-549f-4a72-8657-6a4348f5dca5
Public Version Date
July 06, 2018
Public Version Number
3
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 |