Shaper
9 catalogue numbers from n20 L25, listed by Micro-Mega SA, France, under Broach, Endodontic. 10 manufacturers in China are registered for this product code.
10manufacturers in China registered for this device type
9catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (5), Shanghai (3), Beijing (1). 3 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 |
| Shanghai Toboom Dental Techonology Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Shanghai Smedent Medical Instrument Co., Ltd. | Shanghai | Shanghai | Repacker / relabeller | 30 |
| CDM Center OF Excellence Ltd. | Beijing | Beijing | Manufacturer | 29 |
| Huizhou Videya Technology Co., Ltd. | Huizhou | Guangdong | Manufacturer | 18 |
| Henan Lusterdent Medical Instrument Co., Ltd. | Zhengzhou | Henan | Manufacturer | 15 |
| Shanghai Fanta Dental Materials Co., Ltd. | Shanghai | Shanghai | Manufacturer | 15 |
| Shenzhen Superline Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 12 |
| Dongguan Integrity Medical Instrument Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 5 |
Record
| Listed by | Micro-Mega SA, France |
|---|---|
| FDA product code | EKW |
| Device type | Broach, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-09-10 |
| Record revised | 2026-02-12 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Packaging | Box of 10 |
| Distribution end date | 2021-09-21 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| n20 L25 | 6 | Withdrawn | |
| n10 L21 | 6 | Withdrawn | |
| n10 L25 ISO M10 | 6 | Withdrawn | |
| n25 L25 | 6 | Withdrawn | |
| n15 L21 ISO M10 | 6 | Withdrawn | |
| n20 L21 | 6 | Withdrawn | |
| n15 L25 ISO M10 | 6 | Withdrawn | |
| n25 L21 | 6 | Withdrawn | |
| n30 L25 | 6 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| EdgeBroaches™ | US Endodontics, LLC | 18 |
| Endodontic Hand Instruments | Tulsa Dental Products LLC | 16 |
| Rispi Sonic | Micro-Mega SA | 15 |
| Barbed Broaches | Diadent Group Intl., Inc. | 15 |
| Henry Schein | Henry Schein, Inc. | 14 |
| Dental City | ICP, Inc. | 9 |
| Mani Short Barbed Baorches | Mani, Inc. | 8 |
| Barded Broach Maillefer | Tulsa Dental Products LLC | 8 |
| Spiro® Colorinox® Sterile | Maillefer Instruments Holding Sàrl | 8 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 8 |
| 3D Dental Endo | 3D Dental Designs AND Development, LLC | 8 |
| Health-Tec/DHP Barbed Broaches | Dental Health Products Inc | 8 |
Showing 12 of 57. All products under Broach, 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.