Duns Number:001496777
Device Description: The device is a temporary OTC soft, clear denture reliner consisting of 2 parts (1) a mon The device is a temporary OTC soft, clear denture reliner consisting of 2 parts (1) a monomer liquid and (2) a polymer powder which are mixed together prior to application. This results in a plastic resin paste which is then applied to the denture plate and set in the mouth to cure for a short period of time. Once setting is complete, the excess soft material is able to be trimmed by an enclosed spatula. The application is completely reversible by soaking the denture plate overnight in an over the counter solution of hydrogen peroxide and then removing it by hand.
Catalog Number
-
Brand Name
Reline-It
Version/Model Number
1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K101771,K101771,K101771,K101771,K101771
Product Code
EBP
Product Code Name
Reliner, Denture, Over The Counter
Public Device Record Key
2ab93125-ecc2-469b-9145-e38134917bd3
Public Version Date
November 06, 2020
Public Version Number
5
DI Record Publish Date
July 27, 2016
Package DI Number
50010705400963
Quantity per Package
6
Contains DI Package
00010705400968
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Tray
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |