Thermo Clone VPS
Thermo Clone VPS Fast Set Superlight Body 2x50 ml Refill Kit
6manufacturers in China registered for this device type
29catalogue numbers in this listing
1510(k) clearance
2recalls 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 | Ultradent Products Inc., United States |
|---|---|
| FDA product code | ELW |
| Device type | Material, Impression |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3660 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K082560 |
| Record published | 2016-11-04 |
| Record revised | 2024-12-16 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 18 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4065- | In distribution | |
| 4067- | In distribution | |
| 4057- | In distribution | |
| 4072 | In distribution | |
| 4059- | In distribution | |
| 4058- | In distribution | |
| 4060 | In distribution | |
| 4072- | In distribution | |
| 4066 | In distribution | |
| 4071 | In distribution | |
| 4069 | In distribution | |
| 4070 | In distribution | |
| 4065 | In distribution | |
| 4068 | In distribution | |
| 4060 | In distribution | |
| 4058- | In distribution | |
| 4073- | In distribution | |
| 4069- | In distribution | |
| 4060- | In distribution | |
| 4059- | In distribution | |
| 4071- | In distribution | |
| 4057 | In distribution | |
| 4073 | In distribution | |
| 4070- | In distribution | |
| 4057 | In distribution | |
| 4065 | In distribution | |
| 4068- | In distribution | |
| 4067 | In distribution | |
| 4066- | 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 |
|---|---|
| K940860 | 1994-05-27 |
Recalls
2 of these are Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-02-04 | Class III | Packaging process control | Incorrect packaging of regular set and fast set cartridges. | 100 cartridges | 2013-05-30 |
| 2013-02-04 | Class III | Packaging process control | Incorrect packaging of regular set and fast set cartridges. | 32 cartridges | 2013-05-30 |
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.