K-Reamers
72 catalogue numbers from N055 L21, listed by Micro-Mega SA, France, under Reamer, Pulp Canal, Endodontic. 10 manufacturers in China are registered for this product code.
10manufacturers in China registered for this device type
72catalogue 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 | Micro-Mega SA, France |
|---|---|
| FDA product code | EKP |
| Device type | Reamer, Pulp Canal, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-12-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep dry; Special storage condition: Keep away from sunlight |
| Packaging | Box of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| N055 L21 | 6 | In distribution | |
| N110 L31 | 6 | In distribution | |
| N060 L31 | 6 | In distribution | |
| N080 L21 | 6 | In distribution | |
| N030 L31 | 6 | In distribution | |
| N025 L25 | 6 | In distribution | |
| N040 L21 | 6 | In distribution | |
| N006 L31 | 6 | In distribution | |
| N030 L25 | 6 | In distribution | |
| N080 L25 | 6 | In distribution | |
| N040 L25 | 6 | In distribution | |
| N045 L25 | 6 | In distribution | |
| N055 L25 | 6 | In distribution | |
| N130 L31 | 6 | In distribution | |
| N050 L31 | 6 | In distribution | |
| N090 L21 | 6 | In distribution | |
| N120 L31 | 6 | In distribution | |
| N060 L25 | 6 | In distribution | |
| N080 L31 | 6 | In distribution | |
| N010 L31 | 6 | In distribution | |
| N015/040 L31 | In distribution | ||
| N020 L25 | 6 | In distribution | |
| N040 L31 | 6 | In distribution | |
| N090/140 L25 | In distribution | ||
| n008 L21 | 6 | In distribution | |
| N020 L31 | 6 | In distribution | |
| N120 L21 | 6 | In distribution | |
| N035 L21 | 6 | In distribution | |
| N120 L25 | 6 | In distribution | |
| N025 L31 | 6 | In distribution | |
| N070 L21 | 6 | In distribution | |
| N110 L25 | 6 | In distribution | |
| N090 L31 | 6 | In distribution | |
| N050 L25 | 6 | In distribution | |
| N010 L21 | 6 | In distribution | |
| N060 L21 | 6 | In distribution | |
| N140 L21 | 6 | In distribution | |
| N015 L21 | 6 | In distribution | |
| N090/140 L21 | In distribution | ||
| N015/040 L21 | In distribution | ||
| N045/080 L21 | In distribution | ||
| N045/080 L31 | In distribution | ||
| N045 L21 | 6 | In distribution | |
| N110 L21 | 6 | In distribution | |
| N130 L21 | 6 | In distribution | |
| N015/040 L25 | In distribution | ||
| N130 L25 | 6 | In distribution | |
| N025 L21 | 6 | In distribution | |
| N140 L25 | 6 | In distribution | |
| N006 L21 | 6 | In distribution | |
| N070 L25 | 6 | In distribution | |
| N045 L31 | 6 | In distribution | |
| N015 L31 | 6 | In distribution | |
| N090/140 L31 | In distribution | ||
| N140 L31 | 6 | In distribution | |
| N050 L21 | 6 | In distribution | |
| N008 L31 | 6 | In distribution | |
| N090 L25 | 6 | In distribution | |
| N100 L21 | 6 | In distribution | |
| N035 L31 | 6 | In distribution | |
| N045/080 L25 | In distribution | ||
| N055 L31 | 6 | In distribution | |
| n008 L25 | 6 | In distribution | |
| N100 L25 | 6 | In distribution | |
| N035 L25 | 6 | In distribution | |
| N015 L25 | 6 | In distribution | |
| N030 L21 | 6 | In distribution | |
| N006 L25 | 6 | In distribution | |
| N020 L21 | 6 | In distribution | |
| N070 L31 | 6 | In distribution | |
| N100 L31 | 6 | In distribution | |
| N010 L25 | 6 | 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 |
| 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.