UltraTemp REZ II
UltraTemp REZ II is a temporary resin cement used to retain provisional dental restorations. Its low viscosity, hydrophilic formula is intended for temporary crowns, bridges, inlays and…
UltraTemp REZ II is a temporary resin cement used to retain provisional dental restorations. Its low viscosity, hydrophilic formula is intended for temporary crowns, bridges, inlays and onlays, including provisional prostheses and temporary restorative procedures.
The cement is supplied in a dual-barrel syringe holding base and catalyst. A mixing tip combines the materials as they are expressed into the treatment site.
Listed Item
Sample UltraTemp REZ II Fast Set
Setting Options
The family has Fast Set and Regular Set versions for dental professionals. Fast Set takes 1 to 2 minutes, while Regular Set takes 2 to 3 minutes. The listed sample is the Fast Set formulation.
Who Else Makes It
Concentrated in Shandong (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Rizhao Huge Biomaterials Company, Ltd. | Rizhao | Shandong | Manufacturer | 7 |
| Shenzhen Upcera Dental Technology Co., Ltd. | Shenzhen | Guangdong | Private-label distributor | 6 |
Record
| Listed by | Ultradent Products Inc., United States |
|---|---|
| FDA product code | EMA |
| Device type | Cement, Dental |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3275 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K211237 |
| Record published | 2022-01-07 |
| Record revised | 2023-01-13 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S6061 | In distribution | |
| 6061 | In distribution | |
| 6060 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GC Fuji II LC® | GC America Inc. | 78 |
| Equia® | GC America Inc. | 73 |
| Riva SC | SDI Ltd. | 72 |
| Denture Base | American Tooth Industries | 61 |
| Riva LC | SDI Ltd. | 59 |
| GC Fuji IX GP® | GC America Inc. | 58 |
| GlasIonomer FX-LC | Shofu Dental Corp. | 45 |
| Henry Schein | Henry Schein, Inc. | 35 |
| Esthet-X®flow Liquid Micro Hybrid | Dentsply LLC | 24 |
| Photac™ Fil Quick Aplicap™ | 3M Deutschland GmbH | 24 |
| Ketac™ Fil Plus Aplicap™ | 3M Deutschland GmbH | 23 |
| Ultra-Bond® | DEN-MAT Holdings, LLC | 23 |
Showing 12 of 780. All products under Cement, Dental
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K211237 | 2021-07-13 |
| K111836 | 2011-09-16 |
| K111017 | 2011-06-06 |
| K080768 | 2008-04-11 |
| K060334 | 2006-02-23 |
| K994261 | 2000-02-02 |
| K964808 | 1997-02-26 |
| K964809 | 1997-01-02 |
| K941065 | 1994-06-16 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.