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 LCR kit contains 20gm LCR Adhesive paste in tips, 1 x 6cc Assure Universal Bonding Resin, 23 g Liquid Etching Agent and Mixing accessories.
Catalog Number
LCRETAS
Brand Name
Light Cure Retainer
Version/Model Number
LCRETAS
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 21, 2017
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
-
Product Code
EBI
Product Code Name
Resin, Denture, Relining, Repairing, Rebasing
Public Device Record Key
1b0e2c57-361c-4ddb-af0f-c675230e0c90
Public Version Date
October 29, 2018
Public Version Number
4
DI Record Publish Date
August 17, 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 |