K-Reamers
K-Reamer
10manufacturers in China registered for this device type
103catalogue 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 | Tulsa Dental Products LLC, 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 | 2022-10-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 05325020R | 6 | In distribution | |
| 05325030R | 6 | In distribution | |
| 05331008R | 6 | In distribution | |
| 05328006R | 6 | In distribution | |
| 05325110R | 6 | In distribution | |
| 05328110R | 6 | In distribution | |
| 05331110R | 6 | In distribution | |
| 05331025R | 6 | In distribution | |
| 05325030R | 6 | In distribution | |
| 05331010R | 6 | In distribution | |
| 05328030R | 6 | In distribution | |
| 05321025R | 6 | In distribution | |
| 05325008R | 6 | In distribution | |
| 05325010R | 6 | In distribution | |
| 05331170R | 6 | In distribution | |
| 05325006R | 6 | In distribution | |
| 05325080R | 6 | In distribution | |
| 05331030R | 6 | In distribution | |
| 05328006R | 6 | In distribution | |
| 05325045R | 6 | In distribution | |
| 05325165R | 6 | In distribution | |
| 05325008R | 6 | In distribution | |
| 05328050R | 6 | In distribution | |
| 05328045R | 6 | In distribution | |
| 05331050R | 6 | In distribution | |
| 05321006R | 6 | In distribution | |
| 05331140R | 6 | In distribution | |
| 05328025R | 6 | In distribution | |
| 05328100R | 6 | In distribution | |
| 05328045R | 6 | In distribution | |
| 05321170R | 6 | In distribution | |
| 05325006R | 6 | In distribution | |
| 05331010R | 6 | In distribution | |
| 05321015R | 6 | In distribution | |
| 05321165R | 6 | In distribution | |
| 05331165R | 6 | In distribution | |
| 05321090R | 6 | In distribution | |
| 05331015R | 6 | In distribution | |
| 05331015R | 6 | In distribution | |
| 05331090R | 6 | In distribution | |
| 05321008R | 6 | In distribution | |
| 05325060R | 6 | In distribution | |
| 05328055R | 6 | In distribution | |
| 05321045R | 6 | In distribution | |
| 05325025R | 6 | In distribution | |
| 05328165R | 6 | In distribution | |
| 05328080R | 6 | In distribution | |
| 05328020R | 6 | In distribution | |
| 05331006R | 6 | In distribution | |
| 05321020R | 6 | In distribution | |
| 05328060R | 6 | In distribution | |
| 05321050R | 6 | In distribution | |
| 05325010R | 6 | In distribution | |
| 05331006R | 6 | In distribution | |
| 05321030R | 6 | In distribution | |
| 05325040R | 6 | In distribution | |
| 05325050R | 6 | In distribution | |
| 05328080R | 6 | In distribution | |
| 05321170R | 6 | In distribution | |
| 05328070R | 6 | In distribution | |
| 05321035R | 6 | In distribution | |
| 05328030R | 6 | In distribution | |
| 05331100R | 6 | In distribution | |
| 05331025R | 6 | In distribution | |
| 05321035R | 6 | In distribution | |
| 05325020R | 6 | In distribution | |
| 05331140R | 6 | In distribution | |
| 05328060R | 6 | In distribution | |
| 05321090R | 6 | In distribution | |
| 05328008R | 6 | In distribution | |
| 05331170R | 6 | In distribution | |
| 05328090R | 6 | In distribution | |
| 05325035R | 6 | In distribution | |
| 05328020R | 6 | In distribution | |
| 05321015R | 6 | In distribution | |
| 05331020R | 6 | In distribution | |
| 05325040R | 6 | In distribution | |
| 05325015R | 6 | In distribution | |
| 05331110R | 6 | In distribution | |
| 05321045R | 6 | In distribution | |
| 05325060R | 6 | In distribution | |
| 05325080R | 6 | In distribution | |
| 05331165R | 6 | In distribution | |
| 05328025R | 6 | In distribution | |
| 05328040R | 6 | In distribution | |
| 05331020R | 6 | In distribution | |
| 05325165R | 6 | In distribution | |
| 05325070R | 6 | In distribution | |
| 05325170R | 6 | In distribution | |
| 05328035R | 6 | In distribution | |
| 05321010R | 6 | In distribution | |
| 05321040R | 6 | In distribution | |
| 05321165R | 6 | In distribution | |
| 05321030R | 6 | In distribution | |
| 05331130R | 6 | In distribution | |
| 05328090R | 6 | In distribution | |
| 05331130R | 6 | In distribution | |
| 05328165R | 6 | In distribution | |
| 05321110R | 6 | In distribution | |
| 05331030R | 6 | In distribution | |
| 05321020R | 6 | In distribution | |
| 05321100R | 6 | In distribution | |
| 05321010R | 6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Henry Schein | Henry Schein, Inc. | 133 |
| Mani Reamers | Mani, Inc. | 106 |
| 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 |
| SafeSiders | Essential Dental Systems, Inc. | 40 |
| 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.