Affinis
AFFINIS PRECIOUS Trial Kit light body 1 x 50ml + regular body 1 x 50ml
6manufacturers in China registered for this device type
25catalogue numbers in this listing
2510(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 | DENT4YOU AG, Switzerland |
|---|---|
| FDA product code | ELW |
| Device type | Material, Impression |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3660 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2025-06-16 |
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 |
|---|---|---|
| 60019776 | In distribution | |
| 6682 | In distribution | |
| 6587 | In distribution | |
| 6531 | In distribution | |
| 6535 | In distribution | |
| 3851 | In distribution | |
| 6582 | In distribution | |
| 6511 | In distribution | |
| 6580 | In distribution | |
| 6775 | In distribution | |
| 6620 | In distribution | |
| 6501 | In distribution | |
| 6585 | In distribution | |
| 6482 | In distribution | |
| 6611 | In distribution | |
| 6776 | In distribution | |
| 6601 | In distribution | |
| 6472 | In distribution | |
| 6520 | In distribution | |
| 6685 | In distribution | |
| 6487 | In distribution | |
| 6680 | In distribution | |
| 60019554 | In distribution | |
| 6547 | In distribution | |
| 6530 | 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.