Sure-Endo
Sure-Cord Clean, Knitted Non-medicated Gingival Retraction Cord, Size #000.0, 100 in (254cm)
37manufacturers in China registered for this device type
24catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (9), Guangdong (5), Zhejiang (5). 8 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 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| Fomed Industries Inc | Qian Jiang | Hubei | Contract manufacturer | 19 |
| iBrite Suzhou Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Forefront (Xiamen) Medical Devices Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 8 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
Showing 12 of 37. All 37 manufacturers in China registered for Accessories, Retractor, Dental
Record
| Listed by | Sure Dent Corporation, South Korea |
|---|---|
| FDA product code | EIF |
| Device type | Accessories, Retractor, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-05-16 |
| Record revised | 2025-02-25 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store in a dry place. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SCC-0 | In distribution | |
| SC-3 | In distribution | |
| SC-1 | In distribution | |
| SCC-00/S50 | In distribution | |
| SC-00 | In distribution | |
| SCC-000.0 | In distribution | |
| SCC-000/S50 | In distribution | |
| SCC-0/S50 | In distribution | |
| SC-000 | In distribution | |
| SC-2 | In distribution | |
| SCC-1/S50 | In distribution | |
| SC-0 | In distribution | |
| SC-000 | In distribution | |
| SC-3 | In distribution | |
| SCC-000.0/S50 | In distribution | |
| SCC-1 | In distribution | |
| SCC-2/S50 | In distribution | |
| SC-0 | In distribution | |
| SCC-00 | In distribution | |
| SC-2 | In distribution | |
| SCC-000 | In distribution | |
| SC-1 | In distribution | |
| SC-00 | In distribution | |
| SCC-2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Perfit OneML | Vatech mcis Co., Ltd. | 121 |
| Perfit ZR | Vatech mcis Co., Ltd. | 108 |
| OSE | Orthodontic Supply & Equipment Co., Inc. | 36 |
| Neodent | Jjgc Indústria e Comércio de Materiais Dentários S.A. | 23 |
| Kohdent | Kohler Medizintechnik GmbH | 19 |
| Henry Schein | Henry Schein, Inc. | 19 |
| House Brand Dentistry | Frontier Dental Supply Inc | 16 |
| PrimeLoc | IPB Inc | 14 |
| Dentech | Dentech Corp. | 12 |
| Ceka & Preci-Line Attachments | Alphadent Co., Ltd. | 10 |
| Intraoral Cheek Retractors | Ortho Technology, Inc. | 9 |
| DCI | DCI International, LLC | 7 |
Showing 12 of 152. All products under Accessories, Retractor, Dental
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.