Smooth Broach
2 catalogue numbers from n08 L21, listed by Micro-Mega SA, France, under Explorer, Operative. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (4), Shanghai (2), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amedcon Medical Technology (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Elite Dental LAB | Huizhou | Guangdong | Manufacturer | 18 |
| Shumei Industrial (Hebei) Co., Ltd. | Cangzhou | Hebei | Contract manufacturer | 10 |
| Guang Zhou Medclear Medical Device Service Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
| Pengbo (Shenzhen) Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
Record
| Listed by | Micro-Mega SA, France |
|---|---|
| FDA product code | EKB |
| Device type | Explorer, Operative |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-08-26 |
| Record revised | 2026-02-11 (version 2) |
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, manufacturing date, serial number |
| Packaging | Box of 12 |
| Distribution end date | 2020-08-29 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| n08 L21 | 12 | Withdrawn | |
| n15 L21 | 12 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 207 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 196 |
| Hahnenkratt | E. Hahnenkratt Gmbh | 86 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 67 |
| Power Dental USA | Power Dental U.S.A. Inc. | 42 |
| Sklar® | Sklar Corporation | 39 |
| Premier Explorers | Premier Dental Products Co. | 35 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 32 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 30 |
| Zoll-Dental | Zoll-Dental | 29 |
| National Distribution & Contracting Inc. | Nordent Manufacturing Inc | 28 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 26 |
Showing 12 of 77. All products under Explorer, Operative
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.