Virtual
12 catalogue numbers from 562854AN, listed by Ivoclar Vivadent, Inc., Canada, under Material, Impression. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
12catalogue numbers in this listing
2510(k) clearances naming this product code
3recalls on this 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 | Ivoclar Vivadent, Inc., Canada |
|---|---|
| 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 |
| 510(k) | K972027 |
| Record published | 2017-04-07 |
| Record revised | 2025-05-26 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2020-11-17 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 562854AN | Withdrawn | ||
| 573527AN | Withdrawn | ||
| 562855AN | Withdrawn | ||
| 562826AN | Withdrawn | ||
| 562859AN | Withdrawn | ||
| 573524AN | Withdrawn | ||
| 607909AN | 12 | Withdrawn | |
| 562853AN | Withdrawn | ||
| 562858AN | Withdrawn | ||
| 611327AN | Withdrawn | ||
| 562862AN | Withdrawn | ||
| 562852AN | Withdrawn |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 |
|---|---|
| K143575 | 2015-04-03 |
| K060891 | 2006-07-17 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Ultradent Products Inc. | 510(k) number | 2013-02-04 | Class III | Packaging process control | Incorrect packaging of regular set and fast set cartridges. | 32 cartridges | 2013-05-30 |
| Ultradent Products Inc. | 510(k) number | 2013-02-04 | Class III | Packaging process control | Incorrect packaging of regular set and fast set cartridges. | 100 cartridges | 2013-05-30 |
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-11-09 | Class II | Under Investigation by firm | The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase. | US: 2090 units, Canada: 331 units, Australia: 465 units | 2018-06-18 |
| 2016-11-09 | Class II | Under Investigation by firm | The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase. | US: 4659 units, Canada: 729 units | 2018-06-18 |
| 2016-11-09 | Class II | Under Investigation by firm | The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase. | US: 1867 units, Canada: 465 units | 2018-06-18 |
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.