Elastomeric Impression Material
46 catalogue numbers from Type 0 (Bite Registration Dispenser-mix , listed by Shandong Huge Dental Material Corporation, China, under Material, Impression. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
46catalogue numbers in this listing
1510(k) clearance
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 | Shandong Huge Dental Material Corporation, China |
|---|---|
| FDA product code | ELW |
| Device type | Material, Impression |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3660 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K133071 |
| Record published | 2018-10-16 |
| Record revised | 2026-04-16 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2020-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Type 0 (Bite Registration Dispenser-mix Fast Set) | In distribution | |
| Type 0 (Putty Hand-Mix)+Type 3 (Light Body) | In distribution | |
| Type 3 (Light Body) | In distribution | |
| Type 0 (Putty Hand-Mix)+Type 3 (Light Body) | In distribution | |
| Type 1 (Heavy Body Auto-mix Fast Set) | In distribution | |
| Type 1 (Heavy Body Dispenser-mix Fast Set) | In distribution | |
| Teeth Impression Kit | In distribution | |
| Type 0 (Putty Hand-Mix) | In distribution | |
| Teeth Impression Kit | In distribution | |
| Teeth Impression Kit | In distribution | |
| Type 0 (Putty Hand-Mix) | In distribution | |
| Impression kit | In distribution | |
| Type 0 (Putty Auto-Mix) | In distribution | |
| Type 0 (Putty Hand-Mix) | In distribution | |
| Type 0 (Putty Hand-Mix) | In distribution | |
| Impression kit | In distribution | |
| Type 1 (Heavy Body Auto-mix Normal Set) | In distribution | |
| Type 0 (Putty Hand-Mix)+Type 3 (Light Body) | In distribution | |
| Type 0 (Putty Hand-Mix) | In distribution | |
| Type 0 (Putty Hand-Mix) | In distribution | |
| Type 0 (Putty Hand-Mix) | In distribution | |
| Type 2 (Regular Body) | In distribution | |
| Type 1 (Heavy Body Dispenser-mix Normal Set) | In distribution | |
| Type 0 (Bite Registration Dispenser-mix Normal Set) | In distribution | |
| Type 0 (Putty Hand-Mix) | In distribution | |
| Type 0 (Putty Hand-Mix) | In distribution | |
| Impression kit | In distribution | |
| Impression kit | In distribution | |
| Type 0 (Putty Hand-Mix)+Type 3 (Light Body) | In distribution | |
| Type 0 (Putty Hand-Mix) | In distribution | |
| Type 0 (Putty Hand-Mix) | In distribution | |
| Type 0 (Putty Hand-Mix) | In distribution | |
| Type 0 (Putty Hand-Mix)+Type 3 (Light Body) | Withdrawn | |
| Type 0 (Bite Registration Dispenser-mix Fast Set) | Withdrawn | |
| Type 1 (Heavy Body Auto-mix Fast Set) | Withdrawn | |
| Type 0 (Putty Auto-Mix) | Withdrawn | |
| Type 3 (Light Body) | Withdrawn | |
| Type 0 (Putty Hand-Mix) | Withdrawn | |
| Type 0 (Putty Hand-Mix) | Withdrawn | |
| Type 0 (Bite Registration Dispenser-mix Normal Set) | Withdrawn | |
| Type 1 (Heavy Body Dispenser-mix Fast Set) | Withdrawn | |
| Type 1 (Heavy Body Dispenser-mix Normal Set) | Withdrawn | |
| Type 1 (Heavy Body Auto-mix Normal Set) | Withdrawn | |
| Type 2 (Regular Body) | Withdrawn | |
| Type 0 (Putty Hand-Mix)+Type 3 (Light Body) | Withdrawn | |
| Type 0 (Putty Hand-Mix) | Withdrawn |
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 |
| Splash® | DEN-MAT Holdings, LLC | 44 |
| Futar | Kettenbach Gmbh & Co KG | 42 |
Showing 12 of 1,245. All products under Material, Impression
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201684 | 2020-09-24 |
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.