SafeSiders
SafeSiders Refill Size 25/08 25 mm NiTi
10manufacturers in China registered for this device type
40catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (4), Guangdong (3), Anhui (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Anqing Clean Dental Instrument Technology Co., Ltd. | Anqing | Anhui | Manufacturer | 50 |
| Dongguan Wanjin Industrial Co., Ltd. | Dongguang | Guangdong | Remanufacturer | 41 |
| Shanghai Smedent Medical Instrument Co., Ltd. | Shanghai | Shanghai | Repacker / relabeller | 30 |
| Jinyuan Medical Equipment(Tianjin)Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 27 |
| Bgss Company Asia Limited | Zhabei | Shanghai | Contract manufacturer | 25 |
| Shanghai Fanta Dental Materials Co., Ltd. | Shanghai | Shanghai | Manufacturer | 15 |
| Innovative Material & Devices, Inc. | Wuxi | Jiangsu | Contract manufacturer | 13 |
| Shenzhen Superline Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 12 |
| Shanghai Toboom Dental Techonology Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
Record
| Listed by | Essential Dental Systems, Inc., United States |
|---|---|
| FDA product code | EKP |
| Device type | Reamer, Pulp Canal, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-07-17 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5025-25 | In distribution | |
| 5031-30 | In distribution | |
| 5021-20 | In distribution | |
| 5021-00 | In distribution | |
| 5025-25/08 | In distribution | |
| 5031-25 | In distribution | |
| 5021-25/08 | In distribution | |
| 5025-30 | In distribution | |
| 5021-40 | In distribution | |
| 5031-40 | In distribution | |
| 5031-06 | In distribution | |
| 5021-30 | In distribution | |
| 5021-25 | In distribution | |
| 5025-08 | In distribution | |
| 5021-25/06 | In distribution | |
| 5021-30/04 | In distribution | |
| 5025-06 | In distribution | |
| 5025-20 | In distribution | |
| 5031-10 | In distribution | |
| 5025-25/06 | In distribution | |
| 5031-25/06 | In distribution | |
| 5021-08 | In distribution | |
| 5025-GLP | In distribution | |
| 5031-35 | In distribution | |
| 5031-00 | In distribution | |
| 5031-30/04 | In distribution | |
| 5021-15 | In distribution | |
| 5021-GLP | In distribution | |
| 5031-20 | In distribution | |
| 5025-00 | In distribution | |
| 5021-10 | In distribution | |
| 5025-15 | In distribution | |
| 5031-15 | In distribution | |
| 5021-35 | In distribution | |
| 5025-10 | In distribution | |
| 5025-35 | In distribution | |
| 5031-08 | In distribution | |
| 5025-30/04 | In distribution | |
| 5025-40 | In distribution | |
| 5021-06 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Henry Schein | Henry Schein, Inc. | 133 |
| Mani Reamers | Mani, Inc. | 106 |
| K-Reamers | Tulsa Dental Products LLC | 103 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 82 |
| K-Reamers | Micro-Mega SA | 72 |
| M-access® K-Reamer | Maillefer Instruments Holding Sàrl | 69 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 67 |
| Mani Engine Reamers | Mani, Inc. | 64 |
| Optimum | Benco Dental Supply Co. | 60 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 60 |
| Endodontic Hand Instruments | Tulsa Dental Products LLC | 49 |
| Endodontic Hand Instruments | Roydent Dental Products, Inc. | 28 |
Showing 12 of 195. All products under Reamer, Pulp Canal, Endodontic
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.