ItsoClear
Clear Universal Clasps (2.2 mm) 36/pkg
3manufacturers in China registered for this device type
5catalogue 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 | Keystone Industries, United States |
|---|---|
| FDA product code | EHP |
| Device type | Clasp, Preformed |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3285 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-11-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Width 1.8 to 2.2 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1009152 | Width 2.2 mm | 36 | In distribution |
| 1009153 | Width 2.2 mm | 36 | In distribution |
| 1009151 | Width 1.8 mm | 6 | In distribution |
| 1009150M | 3 | In distribution | |
| 1009150 | Width 1.8 mm | 6 | 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.