UDI device identifier
Reline-It 1
UDI device identifier 00010705400968 · MAJESTIC DRUG CO. INC.
Key facts
| Primary DI | 00010705400968 |
|---|---|
| Brand name | Reline-It |
| Version or model | 1 |
| Company | MAJESTIC DRUG CO. INC. |
| DUNS number | 001496777 |
| Product code | EBP |
| GMDN term | Denture reliner, soft, home-use |
| Premarket submission | K101771 |
| Device class | Class II |
| Single use | Yes |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Jul 27, 2016 |
| Version date | Nov 6, 2020 |
| Description | 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… |
At a glance
- 1–9 MAUDE reports citing this UDI
- Yes Linked premarket submission
- No EUDAMED counterpart found
- 1–9 GUDID devices with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About UDI device identifiers (GUDID)
The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.
Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date: