Estemp NE Temporary Cement
EsTemp NE is a light-curing temporary dental filling material. The filing describes its use for cementation of temporary and provisional restorations, including crowns, bridges, inlays and…
EsTemp NE is a light-curing temporary dental filling material. The filing describes its use for cementation of temporary and provisional restorations, including crowns, bridges, inlays and onlays.
The FDA summary compares EsTemp NE with a predicate dental cement and states that safety testing, including biocompatibility testing, was performed. It also references compliance with ISO 3107.
Use
The stated use is cementation of temporary or provisional restorations.
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 | Spident Co., Ltd., South Korea |
|---|---|
| FDA product code | EMA |
| Device type | Cement, Dental |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3275 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K100290 |
| Record published | 2018-08-23 |
| Record revised | 2022-08-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 54, pack of 96, pack of 120 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 101-1012 | 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 |
|---|---|
| K250566 | 2025-06-20 |
| K214076 | 2022-12-19 |
| K134021 | 2014-06-10 |
| K100290 | 2010-02-17 |
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.