Aquasil Ultra Smart Wetting® Imp Material in Digit® Targeted Delivery System
Aquasil Ultra digit® LV Regular Set Smart Wetting® Impression Material, (Teal), with B4™ Optimizer in digit® Targeted Delivery System Cartridge Refill Package - Large Unit Doses
6manufacturers in China registered for this device type
5catalogue 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 | 2022-10-03 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep out of direct sunlight.; Storage environment temperature 18 to 27 °C |
| Distribution end date | 2020-11-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 678041 | 50 LV Regular Set Large Unit Doses, 50 Mixing Tips, 50 Intraoral Tips | 50 | In distribution |
| 678042 | 50 LV Fast Set Small Unit Doses, 50 Mixing Tips, 50 Intraoral Tips | 50 | In distribution |
| 678040 | 50 LV Regular Set Small Unit Doses, 50 Mixing Tips, 50 Intraoral Tips | 50 | In distribution |
| 678241 | 50 LV Regular Set Large Unit Doses, 50 Mixing Tips, 50 Intraoral Tips, 1 6mL Bottle B4™ Surface Optimizer, 50 Flocked Applicator Tips, 1 Dispensing Well | 50 | Withdrawn |
| 678244 | 50 LV Fast Set Small Unit Doses, 50 Mixing Tips, 50 Intraoral Tips, 1 6mL Bottle B4™ Surface Optimizer, 50 Flocked Applicator Tips, 1 Dispensing Well | 50 | 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 |
|---|---|
| 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.