EXAlence™
EXA’lence™ 370, Regular Set, 370mL Cartridge Standard Kit, Heavy Body (Dark Green), 1 x cartridge, 10 x Dynamic Mixing Tips, 1 x Bayonet Locking Ring
6manufacturers in China registered for this device type
96catalogue numbers in this listing
15510(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 | GC America Inc., United States |
|---|---|
| FDA product code | ELW |
| Device type | Material, Impression |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3660 |
| Establishment | Contract manufacturer, Remanufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K041398 |
| Record published | 2016-08-01 |
| Record revised | 2026-01-21 (version 5) |
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 59 to 77 °F; Storage environment temperature 15 to 25 °C |
| Packaging | Carton of 8, carton of 12 |
| Sizes | Total volume 48 to 370 ml |
| Distribution end date | 2022-07-01 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 137863 | In distribution | ||
| 138912 | In distribution | ||
| 137004 | Total Volume 48 ml | In distribution | |
| 138991 | In distribution | ||
| 137902 | Total Volume 370 ml | In distribution | |
| 137805 | In distribution | ||
| 137714 | In distribution | ||
| 137710 | Total Volume 48 ml | In distribution | |
| 137224 | In distribution | ||
| 137370 | Total Volume 370 ml | In distribution | |
| 137404 | In distribution | ||
| 137715 | Total Volume 48 ml | In distribution | |
| 137713 | In distribution | ||
| 137104 | In distribution | ||
| 137864 | Total Volume 370 ml | In distribution | |
| 137304 | In distribution | ||
| 137707 | In distribution | ||
| 153248 | 48 | In distribution | |
| 137707 | In distribution | ||
| 137704 | In distribution | ||
| 137444 | In distribution | ||
| 137709 | In distribution | ||
| 137014 | Total Volume 48 ml | In distribution | |
| 137405 | In distribution | ||
| 137402 | Total Volume 48 ml | In distribution | |
| 137709 | In distribution | ||
| 137014 | Total Volume 48 ml | In distribution | |
| 138991 | In distribution | ||
| 137402 | Total Volume 48 ml | In distribution | |
| 137705 | Total Volume 48 ml | In distribution | |
| 137805 | In distribution | ||
| 137701 | In distribution | ||
| 137719 | In distribution | ||
| 137712 | In distribution | ||
| 137863 | In distribution | ||
| 137224 | In distribution | ||
| 137204 | In distribution | ||
| 137862 | Total Volume 370 ml | In distribution | |
| 137718 | In distribution | ||
| 137700 | Total Volume 48 ml | In distribution | |
| 137713 | In distribution | ||
| 137705 | Total Volume 48 ml | In distribution | |
| 150300 | 100 | In distribution | |
| 137703 | In distribution | ||
| 137715 | Total Volume 48 ml | In distribution | |
| 137717 | In distribution | ||
| 137004 | Total Volume 48 ml | In distribution | |
| 137304 | In distribution | ||
| 137710 | Total Volume 48 ml | In distribution | |
| 137701 | In distribution | ||
| 153248 | 48 | In distribution | |
| 137704 | In distribution | ||
| 137470 | Total Volume 370 ml | In distribution | |
| 159048 | 48 | In distribution | |
| 137444 | In distribution | ||
| 137870 | In distribution | ||
| 137702 | In distribution | ||
| 137708 | In distribution | ||
| 137870 | Total Volume 370 ml | In distribution | |
| 137719 | In distribution | ||
| 137970 | In distribution | ||
| 137700 | Total Volume 48 ml | In distribution | |
| 137864 | Total Volume 370 ml | In distribution | |
| 150300 | 100 | In distribution | |
| 137703 | In distribution | ||
| 137708 | In distribution | ||
| 137170 | In distribution | ||
| 137334 | In distribution | ||
| 137862 | Total Volume 370 ml | In distribution | |
| 137470 | Total Volume 370 ml | In distribution | |
| 137405 | In distribution | ||
| 137717 | In distribution | ||
| 137270 | In distribution | ||
| 137370 | Total Volume 370 ml | In distribution | |
| 137718 | In distribution | ||
| 150004 | 50 | In distribution | |
| 137404 | In distribution | ||
| 159048 | 48 | In distribution | |
| 137902 | In distribution | ||
| 150005 | 50 | In distribution | |
| 137170 | In distribution | ||
| 137702 | In distribution | ||
| 137104 | In distribution | ||
| 138912 | In distribution | ||
| 137714 | In distribution | ||
| 137270 | In distribution | ||
| 137204 | In distribution | ||
| 137334 | In distribution | ||
| 137970 | In distribution | ||
| 150005 | In distribution | ||
| 137712 | In distribution | ||
| 137865 | Withdrawn | ||
| 137669 | Withdrawn | ||
| 137114 | Withdrawn | ||
| 137570 | Withdrawn | ||
| 137519 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Henry Schein | Henry Schein, Inc. | 164 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 124 |
| 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 |
| Futar | Kettenbach Gmbh & Co KG | 42 |
Showing 12 of 1,245. All products under Material, Impression
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K181011 | 2018-07-12 |
| K120521 | 2012-05-10 |
| K110871 | 2011-06-17 |
| K043493 | 2005-03-04 |
| K043471 | 2005-01-27 |
| K041398 | 2004-06-25 |
| K032289 | 2003-10-20 |
| K023751 | 2003-01-22 |
| K022430 | 2002-10-18 |
| K994077 | 2000-01-27 |
| K973343 | 1997-10-21 |
| K970656 | 1997-04-08 |
| K955932 | 1996-03-11 |
| K943388 | 1994-09-12 |
| K933206 | 1993-09-29 |
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.