Aquasil Ultra Smart Wetting® Impression Material Cartridge System
Aquasil Ultra+ Tray Material Hand Mix Soft Putty Regular Set (Orange) with 50mL LV Regular Set Wash Material
6manufacturers in China registered for this device type
72catalogue numbers in this listing
19510(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 | Dentsply LLC, 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, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-21 |
| Record revised | 2024-05-03 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep away from sunlight. |
| Packaging | Box of 8, pack of 8, case of 8, pack of 3, pack of 12, case of 12 |
| Sizes | Total volume 6 to 380 ml |
| Distribution end date | 2024-06-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 678627 | Total Volume 50 ml | 24 | In distribution |
| 678770 | Total Volume 50 ml | 4 | In distribution |
| 678275 | 24 | In distribution | |
| 678773 | 4 (50mL) Cartridges, 12 Mixing Tips | 4 | In distribution |
| 678695 | 2 AU+ Heavy FS 50mL cartridges, 1 AU+ LV FS 50mL cartridge, 1 AU+ XLV FS 50mL cartridge, 12 mix tips, 6 intraoral tips, 1 bottle (14mL) Caulk tray adhesive, 1 AU+ digit LV/XLV FS evaulator kit | In distribution | |
| 678707 | 4 | In distribution | |
| 678697 | 2 (380mL) DECA Cartridges, 20 mixing tips, 1 bayonet ring | 2 | In distribution |
| 678671 | Total Volume 50 ml | 4 | In distribution |
| 678774 | 4 (50mL) Cartridges, 12 Mixing Tips | 4 | In distribution |
| 678706 | 4 | In distribution | |
| 678678 | Total Volume 50 ml | 4 | In distribution |
| 678620 | In distribution | ||
| 678674 | Total Volume 50 ml | 4 | In distribution |
| 678625 | Total Volume 50 ml | 24 | In distribution |
| 678623 | In distribution | ||
| 678601 | Total Volume 50 ml | 24 | In distribution |
| 678686 | 2 (380mL) DECA Cartridges, 20 mixing tips, 1 bayonet ring | 4 | In distribution |
| 678696 | 50 | In distribution | |
| 678684 | Total Volume 380 ml | 4 | In distribution |
| 678771 | Total Volume 50 ml | 4 | In distribution |
| 678673 | Total Volume 50 ml | 4 | In distribution |
| 678676 | 32 (50mL) cartridges, 12 mixing tips | 4 | In distribution |
| 678698 | 50 | In distribution | |
| 678776 | Total Volume 50 ml | 4 | In distribution |
| 678772 | Total Volume 50 ml | 4 | In distribution |
| 678694 | 50 | In distribution | |
| 678703 | 4 | In distribution | |
| 678768 | 4 Cartridges XLV (50mL each), 12 Mixing Tips | 4 | In distribution |
| 678693 | 50 | In distribution | |
| 678704 | 2 | In distribution | |
| 678701 | 4 | In distribution | |
| 678688 | Total Volume 380 ml | 4 | In distribution |
| 678714 | 4 | In distribution | |
| 678649 | In distribution | ||
| 678626 | Total Volume 50 ml | 24 | In distribution |
| 678708 | In distribution | ||
| 678672 | 32 (50mL) cartridges, 12 mixing tips, 12 intraoral tips | 4 | In distribution |
| 678775 | 4 (50mL) Cartridges, 12 Mixing Tips | 4 | In distribution |
| 678713 | 4 | In distribution | |
| 678778 | Total Volume 50 ml | 4 | In distribution |
| 678276 | 24 | In distribution | |
| 678777 | 4 (50mL) Cartridges, 12 Mixing Tips | 4 | In distribution |
| 678602 | Total Volume 50 ml | 24 | In distribution |
| 678415 | 4 (50mL) Cartridges, 12 Mixing Tips | 4 | Withdrawn |
| 678355 | 4 (50mL) Cartridges, 12 Mixing Tips | 4 | Withdrawn |
| 678031 | Withdrawn | ||
| 678032 | Withdrawn | ||
| 678167 | Total Volume 6 ml | Withdrawn | |
| 678779 | 4 | Withdrawn | |
| 678425 | Total Volume 50 ml | 4 | Withdrawn |
| 678621 | Withdrawn | ||
| 678709 | Withdrawn | ||
| 678702 | 50 | Withdrawn | |
| 678250 | Total Volume 50 ml | 4 | Withdrawn |
| 678648 | Withdrawn | ||
| 678691 | Total Volume 50 ml | Withdrawn | |
| 678781 | 4 | Withdrawn | |
| 678130 | 4 (50mL) Cartridges, 1 Bottle B4™ (6mL), 12 Mixing Tips, 50 Flocked Applicator Tips, 1 Dispensing Well | 4 | Withdrawn |
| 678670 | 32 (50mL) cartridges, 12 mixing tips, 12 intraoral tips | 4 | Withdrawn |
| 678150 | Total Volume 50 ml | 4 | Withdrawn |
| 678668 | Total Volume 50 ml | 4 | Withdrawn |
| 678675 | 32 (50mL) cartridges, 12 mixing tips | 4 | Withdrawn |
| 678160 | Total Volume 6 ml | 4 | Withdrawn |
| 678622 | 2 | Withdrawn | |
| 678350 | 4 (50mL) Cartridges, 12 Mixing Tips | 4 | Withdrawn |
| 678855 | Total Volume 50 ml | 2 | Withdrawn |
| 678711 | Withdrawn | ||
| 678712 | Withdrawn | ||
| 678140 | 4 (50mL) Cartridges, 1 Bottle B4™, 12 Mixing Tips, 50 Flocked Applicator Tips, 1 Dispensing Well | 4 | Withdrawn |
| 678865 | 2 (50mL) Cartridges, 6 Mixing Tips | 2 | Withdrawn |
| 678690 | Total Volume 50 ml | Withdrawn | |
| 678885 | Total Volume 50 ml | 2 | 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 |
| 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 |
|---|---|
| K113406 | 2012-02-13 |
| K061427 | 2006-06-26 |
| K021416 | 2002-05-13 |
| K021413 | 2002-05-10 |
| K021410 | 2002-05-08 |
| K973781 | 1997-12-11 |
| K973782 | 1997-12-04 |
| K970433 | 1997-03-27 |
| K952614 | 1996-08-13 |
| K943574 | 1994-08-23 |
| K940685 | 1994-04-28 |
| K884166 | 1989-04-17 |
| K883842 | 1989-03-17 |
| K863288 | 1986-12-01 |
| K862879 | 1986-09-25 |
| K860146 | 1986-03-17 |
| K802362 | 1980-10-10 |
| K801587 | 1980-07-21 |
| K781151 | 1978-08-31 |
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.