Duracetal
Shade D3 Single Shot 6pk Thermoplastic Dental Resin
3manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Guangdong (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Fseven Dental Technology Zhuhai Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 18 |
| Yamahachi Dental Material (Changshu) Co., Ltd. | Changshu | Jiangsu | Manufacturer | 9 |
Record
| Listed by | The Myerson Company Limited, TT |
|---|---|
| FDA product code | EHP |
| Device type | Clasp, Preformed |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3285 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Record published | 2016-09-24 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Weight 8 g; weight 12.5 kg |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SS-D30-6pk | Weight 8 g | In distribution |
| DC-D40-12.5kg | Weight 12.5 kg | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Leone SPA | Leone SPA | 91 |
| Noninium® | Dentaurum GmbH & Co. KG | 27 |
| Zirlux | Henry Schein, Inc. | 27 |
| Keystone Industries | Keystone Industries | 26 |
| Therm-o-Flex® | Dentsply LLC | 20 |
| SCHEU-Anchor | Scheu-Dental Gmbh | 15 |
| Clasp, Preformed | Forestadent Bernhard Förster GmbH | 14 |
| Clasp, Preformed | Dentaurum GmbH & Co. KG | 13 |
| Adams Clasp | Scheu-Dental Gmbh | 12 |
| RMO | RMO | 12 |
| J-Clasp | Scheu-Dental Gmbh | 7 |
| J-Clasp oblique | Scheu-Dental Gmbh | 6 |
Showing 12 of 24. All products under Clasp, Preformed
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.