Edenta
Root fillers " L" - assortment
20manufacturers in China registered for this device type
275catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (5), Anhui (2). 4 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 |
| Digital Dental Depot | Zhuhai | Guangdong | Contract manufacturer | 17 |
| Shanghai Toboom Dental Techonology Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| TF NEW Material SCI AND TEC Co., Ltd. | Huainan | Anhui | Manufacturer | 51 |
| Hefei Mlush Sanitary Products Co., Ltd. | Hefei | Anhui | Manufacturer | 48 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| CDM Center OF Excellence Ltd. | Beijing | Beijing | Manufacturer | 29 |
| Henan Lusterdent Medical Instrument Co., Ltd. | Zhengzhou | Henan | Manufacturer | 15 |
| Chengdu Besmile Medical Technology Co., Ltd. | Chengdu | Sichuan | Manufacturer | 14 |
Showing 12 of 20. All 20 manufacturers in China registered for Drill, Dental, Intraoral
Record
| Listed by | Edenta Etablissement, LI |
|---|---|
| FDA product code | DZA |
| Device type | Drill, Dental, Intraoral |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4130 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-02-03 |
| Record revised | 2024-04-26 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 178.21.204.040 | 4 | In distribution | |
| 6321-3 | 3 | In distribution | |
| NT-06.35 | 6 | In distribution | |
| 174.21.654SO1 | In distribution | ||
| 174.25.654.060 | 6 | In distribution | |
| 171.31.654.025 | 6 | In distribution | |
| 171.28.654SO2 | 6 | In distribution | |
| 174.25.654.070 | 6 | In distribution | |
| 180.19.204.130 | 6 | In distribution | |
| 178.25.204SO | In distribution | ||
| 173.21.654.025 | 6 | In distribution | |
| 173.25.654.080 | 6 | In distribution | |
| 174.31.654.030 | 6 | In distribution | |
| ST-10.35 | 6 | In distribution | |
| 180.19.204.110 | 6 | In distribution | |
| 173.28.654.020 | 6 | In distribution | |
| 171.31.654.070 | 6 | In distribution | |
| 174.31.654.040 | 6 | In distribution | |
| 180.19.204.050 | 6 | In distribution | |
| 174.21.654.045 | 6 | In distribution | |
| 173.28.654.050 | 6 | In distribution | |
| 180.15.204.130 | 6 | In distribution | |
| 173.31.654.030 | 6 | In distribution | |
| 180.19.204.150 | 6 | In distribution | |
| 174.31.654.025 | 6 | In distribution | |
| 173.28.654.015 | 6 | In distribution | |
| 178.25.204.035 | 4 | In distribution | |
| 183.19.204SO | In distribution | ||
| 183.19.204.070 | 6 | In distribution | |
| 6323-3 | 3 | In distribution | |
| 173.28.654.045 | 6 | In distribution | |
| 183.15.204.170 | 6 | In distribution | |
| 171.28.654.010 | 6 | In distribution | |
| 9107.11.654.020 | 6 | In distribution | |
| 9107.11.654.050 | 6 | In distribution | |
| 171.25.654SO2 | In distribution | ||
| 173.21.654.070 | 6 | In distribution | |
| 171.25.654.040 | 6 | In distribution | |
| 9107.11.654.030 | 6 | In distribution | |
| 171.28.654.070 | 6 | In distribution | |
| 173.25.654.015 | 6 | In distribution | |
| 173.21.654.035 | 6 | In distribution | |
| 171.28.654.015 | 6 | In distribution | |
| 171.28.654.050 | 6 | In distribution | |
| 180.15.204.090 | 6 | In distribution | |
| 173.21.654.010 | 6 | In distribution | |
| 171.28.654SO1 | 6 | In distribution | |
| 6332-3 | 3 | In distribution | |
| 174.25.654.010 | 6 | In distribution | |
| 171.21.654.040 | 6 | In distribution | |
| NT-903SO | In distribution | ||
| 173.31.654.060 | 6 | In distribution | |
| 173.25.654.030 | 6 | In distribution | |
| 183.19.204.110 | 6 | In distribution | |
| 180.15.204.070 | 6 | In distribution | |
| 9107.11.654.025 | 6 | In distribution | |
| 178S.21.204.025 | 4 | In distribution | |
| 173.31.654.050 | 6 | In distribution | |
| 171.25.654.025 | 6 | In distribution | |
| 174.25.654.050 | 6 | In distribution | |
| 171.25.654.060 | 6 | In distribution | |
| 173.31.654.010 | 6 | In distribution | |
| 183.19.204.090 | 6 | In distribution | |
| 173.31.654.015 | 6 | In distribution | |
| 6326-3 | 3 | In distribution | |
| 178.21.204SO | In distribution | ||
| 178S.21.204.035 | 4 | In distribution | |
| 174.21.654.010 | 6 | In distribution | |
| 171.28.654.080 | 6 | In distribution | |
| 180.15.204.110 | 6 | In distribution | |
| 174.25.654SO2 | In distribution | ||
| 171.31.654.035 | 6 | In distribution | |
| 174.28.654.055 | 6 | In distribution | |
| 6331-3 | 3 | In distribution | |
| 171.21.654.045 | 6 | In distribution | |
| 174.25.654.040 | 6 | In distribution | |
| 180.19.204.070 | 6 | In distribution | |
| 171.21.654.020 | 6 | In distribution | |
| 178S.25.204.025 | 4 | In distribution | |
| 171.28.654.055 | 6 | In distribution | |
| 174.21.654.080 | 6 | In distribution | |
| 174.21.654.008 | 6 | In distribution | |
| 174.31.654.035 | 6 | In distribution | |
| 173.28.654.025 | 6 | In distribution | |
| 173.31.654SO2 | In distribution | ||
| 171.31.654SO1 | In distribution | ||
| 174.31.654.080 | 6 | In distribution | |
| 178S.25.204.035 | 4 | In distribution | |
| 174.21.654.035 | 6 | In distribution | |
| 180.15.204.150 | 6 | In distribution | |
| 171.31.654.020 | 6 | In distribution | |
| 183.15.204.150 | 6 | In distribution | |
| 173.21.654.060 | 6 | In distribution | |
| 173.31.654.045 | 6 | In distribution | |
| 173.21.654.080 | 6 | In distribution | |
| 171.31.654.050 | 6 | In distribution | |
| 171.25.654.045 | 6 | In distribution | |
| NT-04.25 | 6 | In distribution | |
| 173.21.654.030 | 6 | In distribution | |
| 171.25.654.055 | 6 | In distribution | |
| NT-06.25 | 6 | In distribution | |
| 174.31.654SO1 | In distribution | ||
| 173.28.654.060 | 6 | In distribution | |
| 173.25.654.025 | 6 | In distribution | |
| 178.21.204.035 | 4 | In distribution | |
| 174.28.654.050 | 6 | In distribution | |
| 178S.21.204.040 | 4 | In distribution | |
| 171.21.654SO2 | In distribution | ||
| 171.25.654SO1 | In distribution | ||
| 174.21.654.015 | 6 | In distribution | |
| 178S.21.204SO | In distribution | ||
| 174.28.654.070 | 6 | In distribution | |
| 174.28.654.030 | 6 | In distribution | |
| 171.25.654.015 | 6 | In distribution | |
| 174.21.654.070 | 6 | In distribution | |
| 171.28.654.008 | 6 | In distribution | |
| 183.15.204.090 | 6 | In distribution | |
| 171.21.654.060 | 6 | In distribution | |
| 171.31.654.010 | 6 | In distribution | |
| 180.15.204SO | In distribution | ||
| 173.21.654.050 | 6 | In distribution | |
| 178S.25.204.040 | 4 | In distribution | |
| 6325-3 | 3 | In distribution | |
| 171.28.654.020 | 6 | In distribution | |
| 6327-3 | 3 | In distribution | |
| 173.28.654SO1 | In distribution | ||
| 9107.11.654.040 | 6 | In distribution | |
| 174.21.654.055 | 6 | In distribution | |
| 174.25.654.020 | 6 | In distribution | |
| 174.25.654.045 | 6 | In distribution | |
| 6322-3 | 3 | In distribution | |
| 174.28.654.010 | 6 | In distribution | |
| 171.25.654.035 | 6 | In distribution | |
| 171.21.654.030 | 6 | In distribution | |
| 174.31.654.055 | 6 | In distribution | |
| 183.19.204.170 | 6 | In distribution | |
| 171.28.654.040 | 6 | In distribution | |
| 171.31.654.055 | 6 | In distribution | |
| 174.25.654.080 | 6 | In distribution | |
| 174.25.654.008 | 6 | In distribution | |
| 173.25.654.035 | 6 | In distribution | |
| 183.15.204SO | In distribution | ||
| 183.15.204.130 | 6 | In distribution | |
| 6324-3 | 3 | In distribution | |
| 178.21.204.025 | 4 | In distribution | |
| 171.21.654.080 | 6 | In distribution | |
| 174.31.654.045 | 6 | In distribution | |
| 171.25.654.070 | 6 | In distribution | |
| 178S.21.204.030 | 4 | In distribution | |
| 174.31.654.060 | 6 | In distribution | |
| 174.31.654.020 | 6 | In distribution | |
| 171.21.654.050 | 6 | In distribution | |
| 173.31.654.070 | 6 | In distribution | |
| 174.25.654.015 | 6 | In distribution | |
| 171.28.654.035 | 6 | In distribution | |
| 171.31.654.080 | 6 | In distribution | |
| 173.25.654.070 | 6 | In distribution | |
| NT-06.20 | 6 | In distribution | |
| 173.21.654.008 | 6 | In distribution | |
| 173.28.654.035 | 6 | In distribution | |
| 173.21.654.045 | 6 | In distribution | |
| 6333-3 | 3 | In distribution | |
| 183.15.204.070 | 6 | In distribution | |
| 173.21.654SO2 | In distribution | ||
| 171.21.654.008 | 6 | In distribution | |
| 171.25.654.080 | 6 | In distribution | |
| 173.21.654.055 | 6 | In distribution | |
| 174.25.654.055 | 6 | In distribution | |
| 171.21.654.015 | 6 | In distribution | |
| 178.25.204.040 | 4 | In distribution | |
| 173.31.654.020 | 6 | In distribution | |
| 174.31.654.050 | 6 | In distribution | |
| 173.31.654.040 | 6 | In distribution | |
| 173.25.654.008 | 6 | In distribution | |
| 174.28.654.015 | 6 | In distribution | |
| 174.25.654.025 | 6 | In distribution | |
| 171.28.654.045 | 6 | In distribution | |
| 173.28.654SO2 | In distribution | ||
| 174.31.654SO2 | In distribution | ||
| 174.21.654SO2 | In distribution | ||
| 6330-3 | 3 | In distribution | |
| 173.25.654.020 | 6 | In distribution | |
| 173.21.654SO1 | In distribution | ||
| 173.25.654.055 | 6 | In distribution | |
| 171.25.654.020 | 6 | In distribution | |
| NT-04.20 | 6 | In distribution | |
| 9107.11.654.035 | 6 | In distribution | |
| 174.31.654.070 | 6 | In distribution | |
| 174.28.654.040 | 6 | In distribution | |
| 171.28.654.060 | 6 | In distribution | |
| 173.25.654.045 | 6 | In distribution | |
| 9107.11.654.060 | 6 | In distribution | |
| 171.25.654.010 | 6 | In distribution | |
| 171.31.654.045 | 6 | In distribution | |
| 174.25.654.035 | 6 | In distribution | |
| NT-06.30 | 6 | In distribution | |
| 9107.11.654SO1 | In distribution | ||
| 173.25.654SO1 | In distribution | ||
| 171.31.654.060 | 6 | In distribution | |
| 173.25.654.050 | 6 | In distribution | |
| 174.21.654.060 | 6 | In distribution | |
| 174.25.654.030 | 6 | In distribution | |
| 173.31.654.035 | 6 | In distribution | |
| 173.28.654.080 | 6 | In distribution | |
| 180.15.204.050 | 6 | In distribution | |
| 180.19.204SO | In distribution | ||
| 171.31.654.040 | 6 | In distribution | |
| 178S.25.204.030 | 4 | In distribution | |
| 173.31.654SO1 | In distribution | ||
| 183.15.204.110 | 6 | In distribution | |
| 173.31.654.055 | 6 | In distribution | |
| 171.28.654.025 | 6 | In distribution | |
| 178S.25.204SO | In distribution | ||
| EST-1 | In distribution | ||
| 174.28.654.080 | 6 | In distribution | |
| 183.20.204.165 | 6 | In distribution | |
| 173.31.654.025 | 6 | In distribution | |
| 173.21.654.020 | 6 | In distribution | |
| 174.21.654.030 | 6 | In distribution | |
| 174.28.654.008 | 6 | In distribution | |
| 173.21.654.015 | 6 | In distribution | |
| 174.28.654.035 | 6 | In distribution | |
| 174.31.654.015 | 6 | In distribution | |
| 171.21.654.055 | 6 | In distribution | |
| 174.28.654SO1 | In distribution | ||
| 174.21.654.020 | 6 | In distribution | |
| 173.28.654.040 | 6 | In distribution | |
| 173.28.654.070 | 6 | In distribution | |
| 173.25.654.010 | 6 | In distribution | |
| 171.21.654.070 | 6 | In distribution | |
| 178.25.204.025 | 4 | In distribution | |
| 174.28.654SO2 | In distribution | ||
| 171.31.654.030 | 6 | In distribution | |
| 174.31.654.008 | 6 | In distribution | |
| 171.31.654.015 | 6 | In distribution | |
| 171.31.654SO2 | In distribution | ||
| NT-04.35 | 6 | In distribution | |
| 173.28.654.055 | 6 | In distribution | |
| 180.19.204.090 | 6 | In distribution | |
| NT-901SO | In distribution | ||
| 173.31.654.008 | 6 | In distribution | |
| 178.21.204.030 | 4 | In distribution | |
| 174.25.654SO1 | In distribution | ||
| 171.21.654SO1 | In distribution | ||
| 174.21.654.050 | 6 | In distribution | |
| 171.21.654.035 | 6 | In distribution | |
| 174.21.654.025 | 6 | In distribution | |
| NT-04.30 | 6 | In distribution | |
| 173.25.654.040 | 6 | In distribution | |
| 174.28.654.060 | 6 | In distribution |
Showing 250 of 275 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Neobiotech Implant System | Neobiotech Co., Ltd. | 685 |
| Jota | Jota AG | 307 |
| OneGuide Taper Drill | Osstem Implant Co., Ltd. | 291 |
| Neodent | Jjgc Indústria e Comércio de Materiais Dentários S.A. | 286 |
| 122 Taper Drill | Osstem Implant Co., Ltd. | 285 |
| Taper Drill | Osstem Implant Co., Ltd. | 279 |
| Bone Compaction Drill | Osstem Implant Co., Ltd. | 200 |
| Dental Surgical Drill | Cowellmedi Co., Ltd. | 195 |
| Twist Drill | Osstem Implant Co., Ltd. | 169 |
| Bondent | United Dental Changzhou | 166 |
| Ritter Implants Dental System | Ritter Implants GmbH & Co. KG | 156 |
| DIOnavi. Straight Drill | DIO Corporation | 151 |
Showing 12 of 875. All products under Drill, Dental, Intraoral
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.