Henry Schein
Barbed Broaches Ster Purple O
10manufacturers in China registered for this device type
14catalogue 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 | Henry Schein, Inc., United States |
|---|---|
| FDA product code | EKW |
| Device type | Broach, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2020-08-25 |
| Record revised | 2019-10-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1004472 | 10 | In distribution | |
| 1003917 | 10 | In distribution | |
| 1007927 | 10 | In distribution | |
| 1001229 | 10 | In distribution | |
| 1004473 | 10 | In distribution | |
| 1006929 | 10 | In distribution | |
| 1003568 | 10 | In distribution | |
| 1004256 | 10 | In distribution | |
| 1003577 | 10 | In distribution | |
| 1001403 | 10 | In distribution | |
| 1002089 | 10 | In distribution | |
| 1006659 | 10 | In distribution | |
| 1004259 | 10 | In distribution | |
| 1002487 | 10 | In distribution |
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 |
| Dental City | ICP, Inc. | 9 |
| Shaper | Micro-Mega SA | 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.