Radix Anchor
Radix-Anchor Drills Root Facer Type RA Size 2
10manufacturers in China registered for this device type
8catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (3), Jiangsu (2), Shanghai (2). 2 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 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Shanghai Alwings Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 39 |
| Henan Lusterdent Medical Instrument Co., Ltd. | Zhengzhou | Henan | Manufacturer | 15 |
| Shanghai Fanta Dental Materials Co., Ltd. | Shanghai | Shanghai | Manufacturer | 15 |
| Shenzhen Forever Medical Devices Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 9 |
Record
| Listed by | Tulsa Dental Products LLC, United States |
|---|---|
| FDA product code | ELR |
| Device type | Post, Root Canal |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3810 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-11-01 |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 671620 | 72 | In distribution | |
| 671631 | 6 | In distribution | |
| 671632 | 6 | In distribution | |
| 671622 | 72 | In distribution | |
| 671650 | In distribution | ||
| 671630 | 6 | In distribution | |
| 671652 | In distribution | ||
| 671630 | 6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Henry Schein | Henry Schein, Inc. | 115 |
| ParaPost XP | Coltene/Whaledent Gmbh & Co. KG | 111 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 90 |
| Hahnenkratt | E. Hahnenkratt Gmbh | 89 |
| Surtex | Dentatus AB | 84 |
| ParaPost | Coltene/Whaledent Gmbh & Co. KG | 46 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 44 |
| Two Striper | Abrasive Technology, LLC | 43 |
| Johnson-Promident | Young Innovations Inc. | 41 |
| Flexi-Post | Essential Dental Systems, Inc. | 40 |
| Biolight | Synca Marketing | 37 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 37 |
Showing 12 of 231. All products under Post, Root Canal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K922931 | 1994-05-26 |
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.