Speedex
Speedex is a two-component dental impression material based on polysiloxanes. After its base and activator are mixed, the materials form pastes used individually or together as impression…
Speedex is a two-component dental impression material based on polysiloxanes. After its base and activator are mixed, the materials form pastes used individually or together as impression material.
The filing describes use with an impression tray and conventional impression techniques. The named products include putty, putty soft, light body, medium and a universal activator for creating dental impressions.
Listed Item
Speedex Univ. ACT. SGL 60ML
Listed Applications
The FDA indications vary by product: they include primary and pickup impressions, study and orthodontic models, relining, prosthetic impressions and monophase techniques.
Who Else Makes It
Concentrated in Henan (1), Shandong (1), Jiangxi (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hygedent Inc. | Beijing | Beijing | Contract manufacturer | 1 |
| Zhengzhou Huaer Electro-Optics Technology Co., Ltd. | Zhengzhou | Henan | Contract manufacturer | 21 |
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Jiangxi Dentalbright Technology Co., Ltd. | Jiujiang | Jiangxi | Contract manufacturer | 12 |
| Sunrise Dental Laboratory, Ltd. | Kowloon | Hong Kong | Manufacturer | 5 |
| Chemoment Materials Co., Ltd. | Hefei | Anhui | Manufacturer | 3 |
Record
| Listed by | DENT4YOU AG, Switzerland |
|---|---|
| FDA product code | ELW |
| Device type | Material, Impression |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3660 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K242360 |
| Record published | 2025-04-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3650 EM | In distribution | |
| 4986 EM | In distribution | |
| 4990 EM | In distribution | |
| 60023572 | In distribution | |
| 4980 EM | In distribution | |
| 4980 | In distribution | |
| 4990 | In distribution | |
| 4970 EM | In distribution | |
| 60023572 EM | In distribution | |
| 4970 | In distribution | |
| 4986 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Henry Schein | Henry Schein, Inc. | 164 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 124 |
| EXAlence™ | GC America Inc. | 96 |
| MARK3 | Cargus International, Inc | 75 |
| Panasil | Kettenbach Gmbh & Co KG | 73 |
| Aquasil Ultra Smart Wetting® Impression Material Cartridge System | Dentsply LLC | 72 |
| DentMix | IPB Inc | 70 |
| Affinis | Coltène/Whaledent AG | 67 |
| Take 1 Advanced | Kerr Corporation | 54 |
| MDC Dental | MDC Dental | 49 |
| Elastomeric Impression Material | Shandong Huge Dental Material Corporation | 46 |
| Splash® | DEN-MAT Holdings, LLC | 44 |
Showing 12 of 1,245. All products under Material, Impression
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250969 | 2025-06-27 |
| K242360 | 2024-11-15 |
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.