Mark II
The Mark II CR Syringe is intended for use as a dispensing mechanism for adhesive tips.
10manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (4), Jiangsu (3), Guangdong (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Hangzhou Westlake Biomaterial Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 13 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Hangzhou Haizhu MIM Products Co., Ltd. | Hangzhou | Zhejiang | Exporter | 28 |
| Orthguide Medical Technology (Jiangsu) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 17 |
| Zhejiang Protect Medical Equipment Co., Ltd. | Anji | Zhejiang | Manufacturer | 16 |
| Zhejiang Shinye Medical Technology Corp.,Ltd | Hangzhou | Zhejiang | Manufacturer | 10 |
| Wuxi TP Orthodontics Material Co., Ltd. | Wuxi | Jiangsu | Repacker / relabeller | 9 |
Record
| Listed by | Reliance Orthodontic Products, Inc., United States |
|---|---|
| FDA product code | ECP |
| Device type | Instrument, Ligature Tucking, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-07-25 |
| Record revised | 2019-08-21 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Special storage condition: Store at ambient conditions. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CRII | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HU-Friedy | HU-Friedy MFG Co., LLC | 76 |
| Ortho Arch | Ortho Arch Company Inc | 41 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 36 |
| Hu-Friedy MFG Co., LLC. | HU-Friedy MFG Co., LLC | 19 |
| Schwert | A. Schweickhardt Gmbh & Co. KG | 11 |
| Leone SPA | Leone SPA | 10 |
| Power Dental USA | Power Dental U.S.A. Inc. | 9 |
| Spectrum | Ortho Arch Company Inc | 9 |
| J & J Instruments | J & J Instruments, LLC | 8 |
| General Instruments | American Orthodontics | 8 |
| Quinelato | Schobell Industrial Ltda | 8 |
| Preformed Ligature Wire | Ortho Arch Company Inc | 6 |
Showing 12 of 89. All products under Instrument, Ligature Tucking, Orthodontic
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.