Blu-Mousse®
Snap-In Intraoral Tip for Use in S439K, S445 & S496 Mixing Tips (Pkg. of 50 pcs.)
6manufacturers in China registered for this device type
24catalogue numbers in this listing
3510(k) clearances naming this product code
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 | Parkell, Inc., United States |
|---|---|
| FDA product code | ELW |
| Device type | Material, Impression |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3660 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2018-09-14 |
| Record revised | 2023-12-21 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 25 °C; Special storage condition: Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with cap tightly screwed on. |
| Packaging | Pack of 2 |
| Distribution end date | 2023-11-29 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| S436 | In distribution | ||
| S439IOT | 50 | In distribution | |
| S440S | 2 | In distribution | |
| S439K | 2 | In distribution | |
| S438S | 2 | In distribution | |
| S457S | 2 | In distribution | |
| S440S-K | 2 | In distribution | |
| S448S | 2 | In distribution | |
| S457S-K | 2 | In distribution | |
| S436-K | In distribution | ||
| S438S-K | 2 | In distribution | |
| S437S | 2 | In distribution | |
| S457 | 2 | Withdrawn | |
| S438 | Withdrawn | ||
| S438-K | 2 | Withdrawn | |
| S457 | Withdrawn | ||
| S457-K | 2 | Withdrawn | |
| S448S | Withdrawn | ||
| S437S | Withdrawn | ||
| S438S | Withdrawn | ||
| S438 | 2 | Withdrawn | |
| S440S | Withdrawn | ||
| S457S | Withdrawn | ||
| S436 | 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 |
| 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 |
|---|---|
| K962741 | 1996-09-06 |
| K905032 | 1991-03-15 |
| K792363 | 1980-01-09 |
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.