UDI device identifier
DenTemp Custom 1
UDI device identifier 00010705400814 · MAJESTIC DRUG CO. INC.
Key facts
| Primary DI | 00010705400814 |
|---|---|
| Brand name | DenTemp Custom |
| Version or model | 1 |
| Company | MAJESTIC DRUG CO. INC. |
| DUNS number | 001496777 |
| Product code | EMB |
| GMDN term | Home-use dental cement |
| Premarket submission | K821581 |
| Device class | Class I |
| Single use | Yes |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Jul 27, 2016 |
| Version date | Jul 6, 2018 |
| Description | Dentemp Custom is a Zinc Oxide / Eugenol temporary dental cement for re-cementing loose caps or crowns and replacing lost fillings |
At a glance
- None MAUDE reports citing this UDI
- Yes Linked premarket submission
- No EUDAMED counterpart found
- 10–99 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: