J-Temp
J-Temp is a flowable, light-cured temporary dental resin delivered by syringe. It forms temporary restorations and can splint implant impression copings to resist distortion during…
J-Temp is a flowable, light-cured temporary dental resin delivered by syringe. It forms temporary restorations and can splint implant impression copings to resist distortion during impression taking.
The cured resin can provide support for isolation clamps and act as a barrier to endodontic irrigants. These uses take advantage of its ability to remain in place after application and curing.
Listed Item
J-Temp Temporary Resin 4 pack
Orthodontic Use
The material is also indicated for bite ramps and temporary occlusal buildups during orthodontic treatment. Its role is temporary shaping or support rather than a permanent restorative cement.
Who Else Makes It
Concentrated in Guangdong (3), Shandong (2), Jilin (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Aidite (Qinhuangdao) Technology Co., Ltd. | Qinhuangdao | Hebei | Repacker / relabeller | 17 |
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Liaoning Upcera Co., Ltd. | Benxi | Liaoning | Contract manufacturer | 10 |
| Shenzhen Upcera Digital Dental Technology Co., Ltd. | Shenzhen | Guangdong | Exporter | 10 |
| Rizhao Huge Biomaterials Company, Ltd. | Rizhao | Shandong | Manufacturer | 7 |
| Hangzhou SHINING3D Dental Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 7 |
| Shenzhen Piocreat 3D Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
| Shenzhen Upcera Dental Technology Co., Ltd. | Shenzhen | Guangdong | Private-label distributor | 6 |
| Sincera Technology (Changchun) Co., Ltd. | Changchun | Jilin | Manufacturer | 2 |
| Sino-Dentex Co., Ltd. | Changchun | Jilin | Manufacturer | 2 |
Record
| Listed by | Ultradent Products Inc., United States |
|---|---|
| FDA product code | EBF |
| Device type | Material, Tooth Shade, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3690 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K221909 |
| Record published | 2023-01-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 2 to 27 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4897- | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tooth Shade Resin Material | Liaoning Upcera Co., Ltd. | 4,808 |
| Gradia® | GC America Inc. | 548 |
| G-CAM | Graphenano Dental, SL | 320 |
| Vitavm LC | Vita – Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft | 261 |
| G-aenial™ | GC America Inc. | 225 |
| Ena HRI ® | Micerium SPA | 221 |
| Mazic Duro | Vericom Co., Ltd. | 206 |
| Ceramage | Shofu Dental Corp. | 204 |
| Filtek™ | 3M Company | 188 |
| SR Nexco | Ivoclar Vivadent Aktiengesellschaft | 181 |
| Aidite | Aidite (Qinhuangdao) Technology Co., Ltd. | 166 |
| Tetric EvoCeram | Ivoclar Vivadent Aktiengesellschaft | 163 |
Showing 12 of 2,059. All products under Material, Tooth Shade, Resin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K262228 | 2026-07-01 |
| K240694 | 2024-03-15 |
| K221909 | 2022-07-01 |
| K151094 | 2015-07-21 |
| K043119 | 2004-12-17 |
| K974413 | 1998-02-02 |
| K974282 | 1998-01-29 |
| K971898 | 1997-06-24 |
| K965060 | 1997-01-31 |
| K953525 | 1995-08-28 |
| K950859 | 1995-03-23 |
| K932227 | 1993-09-13 |
| K931867 | 1993-09-09 |
| K921598 | 1992-09-09 |
| K921602 | 1992-09-09 |
| K921407 | 1992-09-09 |
| K921409 | 1992-09-09 |
Recalls
4 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2024-08-02 | Class II | Material/Component Contamination | Due to a manufacturing issue, red particulates present in the expressed composite. | 560 | |
| 2024-08-02 | Class II | Material/Component Contamination | Due to a manufacturing issue, red particulates present in the expressed composite. | 2450 | |
| 2024-08-02 | Class II | Material/Component Contamination | Due to a manufacturing issue, red particulates present in the expressed composite. | 90 | |
| 2020-08-31 | Class II | Under Investigation by firm | Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous. | 412 syringes (206 kits) | 2021-10-18 |
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.