Edenta
Titanium polisher unmounted - gray
15manufacturers in China registered for this device type
1,065catalogue numbers in this listing
Who Else Makes It
Concentrated in Hebei (4), Shanghai (4), Jiangsu (3). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Toboom Dental Techonology Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Anqing Clean Dental Instrument Technology Co., Ltd. | Anqing | Anhui | Manufacturer | 50 |
| Cangzhou Lankang Medical Instruments Developing Co., Ltd. | Cangzhou | Hebei | Manufacturer | 40 |
| Shanghai Alwings Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 39 |
| Huanghua DK Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 37 |
| Henan Baistra Medical Devices Limited | Zhengzhou | Henan | Manufacturer | 34 |
| Tangshan Zhengtong Exhibition Co., Ltd. | Tangshan | Hebei | Manufacturer | 34 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
Showing 12 of 15. All 15 manufacturers in China registered for Wheel, Polishing Agent
Record
| Listed by | Edenta Etablissement, LI |
|---|---|
| FDA product code | EJQ |
| Device type | Wheel, Polishing Agent |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6010 |
| 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 |
| Single use | Yes |
| 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 |
|---|---|---|---|
| 0530RA-12 | 12 | In distribution | |
| DM76-100 | 100 | In distribution | |
| TGTK | In distribution | ||
| R2540HP | In distribution | ||
| R2640RA-6 | 6 | In distribution | |
| 4039RA-6 | 6 | In distribution | |
| 1121UM-10 | 10 | In distribution | |
| 4060 | In distribution | ||
| R2020HP | In distribution | ||
| 1261UM-50 | 50 | In distribution | |
| 1172UM-100 | 100 | In distribution | |
| 1257RA-100 | 100 | In distribution | |
| 0738RA-100 | 100 | In distribution | |
| MT0674HP-6 | 6 | In distribution | |
| 0632HP-6 | 6 | In distribution | |
| 30053FG-6 | 6 | In distribution | |
| BM731.065HP-100 | 100 | In distribution | |
| 1240RA-100 | 100 | In distribution | |
| 0033RA-12 | 12 | In distribution | |
| 4007HP-6 | 6 | In distribution | |
| AS06.030FG-12 | 12 | In distribution | |
| GC23-100 | 100 | In distribution | |
| 19050SO | In distribution | ||
| 1107HP-100 | 100 | In distribution | |
| TB41-100 | 100 | In distribution | |
| TB44-12 | 12 | In distribution | |
| 30040SO | In distribution | ||
| 4011HP-6 | 6 | In distribution | |
| EM40-12 | 12 | In distribution | |
| 3047HP | In distribution | ||
| 0642HP-6 | 6 | In distribution | |
| ST2640RA-6 | 6 | In distribution | |
| 20038RA-6 | 6 | In distribution | |
| 0150HP-100 | 100 | In distribution | |
| 0143HP-100 | 100 | In distribution | |
| TB91-100 | 100 | In distribution | |
| 11009SO | In distribution | ||
| 0333RA-100 | 100 | In distribution | |
| 0524UM-12 | 12 | In distribution | |
| 1823UM-12 | 12 | In distribution | |
| BM732.050HP-12 | 12 | In distribution | |
| 0654HP-100 | 100 | In distribution | |
| 0679HP-6 | 6 | In distribution | |
| TM10-100 | 100 | In distribution | |
| PC11-100 | 100 | In distribution | |
| ST2530HP | In distribution | ||
| 1803UM-100 | 100 | In distribution | |
| 1935RA-6 | 6 | In distribution | |
| 2121 | 5 | In distribution | |
| GM44-100 | 100 | In distribution | |
| 1473RA-100 | 100 | In distribution | |
| R1020HP | In distribution | ||
| EM10-100 | 100 | In distribution | |
| 18132RA-12 | 12 | In distribution | |
| AC44-100 | 100 | In distribution | |
| BM732.050HP-100 | 100 | In distribution | |
| 0101UM-12 | 12 | In distribution | |
| 0374HP-100 | 100 | In distribution | |
| TB45-12 | 12 | In distribution | |
| 0534RA-100 | 100 | In distribution | |
| 0146HP-100 | 100 | In distribution | |
| GM733.035HP-12 | 12 | In distribution | |
| 1475RA-100 | 100 | In distribution | |
| 1702UM-12 | 12 | In distribution | |
| 1235RA-12 | 12 | In distribution | |
| TG43-12 | 12 | In distribution | |
| BR02UM-100 | 100 | In distribution | |
| 11001UM-100 | 100 | In distribution | |
| 3010HP | In distribution | ||
| 0050HP-100 | 100 | In distribution | |
| PC10-100 | 100 | In distribution | |
| 2140 | 5 | In distribution | |
| AM10-100 | 100 | In distribution | |
| 0375HP-100 | 100 | In distribution | |
| FM05-100 | 100 | In distribution | |
| R2540RA-6 | 6 | In distribution | |
| AS14.025RA-12 | 12 | In distribution | |
| 1109SO | In distribution | ||
| 0036RA-12 | 12 | In distribution | |
| 304HP | In distribution | ||
| 900.400SO | In distribution | ||
| TM01-100 | 100 | In distribution | |
| 1110 | In distribution | ||
| 1103UM-100 | 100 | In distribution | |
| 0935RA-12 | 12 | In distribution | |
| 0433RA-100 | 100 | In distribution | |
| 1323UM-50 | 50 | In distribution | |
| 0149HP-100 | 100 | In distribution | |
| 4038RA-6 | 6 | In distribution | |
| BLAU0411UM-100 | 100 | In distribution | |
| 0322UM-100 | 100 | In distribution | |
| 7000.220UM-25 | 25 | In distribution | |
| 342HP | In distribution | ||
| 0205UM-100 | 100 | In distribution | |
| RM624.060HP-12 | 12 | In distribution | |
| ST2540RA-6 | 6 | In distribution | |
| 0038RA-12 | 12 | In distribution | |
| MT0677HP-6 | 6 | In distribution | |
| TG47-6 | 6 | In distribution | |
| R2830RA-6 | 6 | In distribution | |
| 19038RA-100 | 100 | In distribution | |
| 1478RA-100 | 100 | In distribution | |
| 7007.400UM-10 | 10 | In distribution | |
| 0536RA-12 | 12 | In distribution | |
| 3033RA-6 | 6 | In distribution | |
| ST2740RA-6 | 6 | In distribution | |
| 0432RA-12 | 12 | In distribution | |
| 4023RA-6 | 6 | In distribution | |
| 3036RA-6 | 6 | In distribution | |
| 0400UM-100 | 100 | In distribution | |
| 1932RA-6 | 6 | In distribution | |
| 3042HP | In distribution | ||
| 4018HP-6 | 6 | In distribution | |
| EM11-100 | 100 | In distribution | |
| 0532RA-100 | 100 | In distribution | |
| 343HP | In distribution | ||
| 0659HP-6 | 6 | In distribution | |
| 0631HP-100 | 100 | In distribution | |
| 1108 | In distribution | ||
| 1423UM-100 | 100 | In distribution | |
| 0653HP-6 | 6 | In distribution | |
| RG731.065HP-12 | 12 | In distribution | |
| 1704UM-100 | 100 | In distribution | |
| 30033RA-6 | 6 | In distribution | |
| 1932RA-100 | 100 | In distribution | |
| 4011HP-100 | 100 | In distribution | |
| 0355RA-100 | 100 | In distribution | |
| 1246RA-100 | 100 | In distribution | |
| 0677HP-6 | 6 | In distribution | |
| 0667HP-6 | 6 | In distribution | |
| 1707UM-12 | 12 | In distribution | |
| 0642HP-100 | 100 | In distribution | |
| 0511UM-12 | 12 | In distribution | |
| AM77-6 | 6 | In distribution | |
| GM733.035HP-100 | 100 | In distribution | |
| 0410UM-12 | 12 | In distribution | |
| 0651HP-6 | 6 | In distribution | |
| GF601.030RA-100 | 100 | In distribution | |
| 0361HP-12 | 12 | In distribution | |
| GM732.050HP-100 | 100 | In distribution | |
| 0738RA-12 | 12 | In distribution | |
| 1252UM-100 | 100 | In distribution | |
| 355FG-100 | 100 | In distribution | |
| 0836RA-12 | 12 | In distribution | |
| TG91-100 | 100 | In distribution | |
| FM23-100 | 100 | In distribution | |
| 0835RA-12 | 12 | In distribution | |
| 1935RA-100 | 100 | In distribution | |
| 1023UM-100 | 100 | In distribution | |
| 18244HP-100 | 100 | In distribution | |
| RM732.050HP-100 | 100 | In distribution | |
| PC44-100 | 100 | In distribution | |
| 0041HP-100 | 100 | In distribution | |
| TB05-12 | 12 | In distribution | |
| WC23-100 | 100 | In distribution | |
| TG45-100 | 100 | In distribution | |
| 0500UM-100 | 100 | In distribution | |
| 30050SO | In distribution | ||
| GM736.065HP-100 | 100 | In distribution | |
| 20035RA-100 | 100 | In distribution | |
| BLAU0410UM-12 | 12 | In distribution | |
| AC10-100 | 100 | In distribution | |
| 0384HP-12 | 12 | In distribution | |
| 0671HP-6 | 6 | In distribution | |
| 4004HP-6 | 6 | In distribution | |
| RM620.050HP-12 | 12 | In distribution | |
| CGTK | In distribution | ||
| AS03.025FG-100 | 100 | In distribution | |
| RM732.050HP-12 | 12 | In distribution | |
| 1039RA-6 | 6 | In distribution | |
| MT0664HP-6 | 6 | In distribution | |
| EM01-12 | 12 | In distribution | |
| 0005UM-12 | 12 | In distribution | |
| 0130RA-12 | 12 | In distribution | |
| 0365RA-12 | 12 | In distribution | |
| 0394HP-100 | 100 | In distribution | |
| 0001UM-12 | 12 | In distribution | |
| SGTK | In distribution | ||
| 19035RA-100 | 100 | In distribution | |
| 19034RA-6 | 6 | In distribution | |
| 0673HP-6 | 6 | In distribution | |
| PF10-100 | 100 | In distribution | |
| 0221UM-100 | 100 | In distribution | |
| 4029HP-100 | 100 | In distribution | |
| MT0654HP-6 | 6 | In distribution | |
| GM671.050HP-12 | 12 | In distribution | |
| 0034RA-100 | 100 | In distribution | |
| AC74-6 | 6 | In distribution | |
| 0435RA-12 | 12 | In distribution | |
| 0136RA-12 | 12 | In distribution | |
| AM77-100 | 100 | In distribution | |
| 0080SO | In distribution | ||
| 3041HP | In distribution | ||
| PF41-100 | 100 | In distribution | |
| 0522UM-12 | 12 | In distribution | |
| 1235RA-100 | 100 | In distribution | |
| FL7000.220UM-25 | 25 | In distribution | |
| 0149HP-6 | 12 | In distribution | |
| AM76-100 | 100 | In distribution | |
| TB23-100 | 100 | In distribution | |
| PF44-100 | 100 | In distribution | |
| 1248RA-100 | 100 | In distribution | |
| 0147HP-100 | 100 | In distribution | |
| GF23-12 | 12 | In distribution | |
| 0655HP-6 | 6 | In distribution | |
| 1933RA-100 | 100 | In distribution | |
| 0055FG-100 | 100 | In distribution | |
| BC02-100 | 100 | In distribution | |
| BC02-12 | 12 | In distribution | |
| 0422UM-12 | 12 | In distribution | |
| GF727.120HP-12 | 12 | In distribution | |
| 1104UM-25 | 25 | In distribution | |
| GF649.025HP-100 | 100 | In distribution | |
| 0535RA-12 | 12 | In distribution | |
| 0391SO | In distribution | ||
| 0030RA-100 | 100 | In distribution | |
| WF11-12 | 12 | In distribution | |
| WM453.100HP-12 | 12 | In distribution | |
| TF10-100 | 100 | In distribution | |
| GC10-12 | 12 | In distribution | |
| 0666HP-6 | 6 | In distribution | |
| PM02-100 | 100 | In distribution | |
| 333RA-6 | 6 | In distribution | |
| 0652HP-6 | 6 | In distribution | |
| 4009HP-6 | 6 | In distribution | |
| 1305UM-100 | 100 | In distribution | |
| AS01.025FG-12 | 12 | In distribution | |
| GF661.025HP-12 | 12 | In distribution | |
| R2840RA-6 | 6 | In distribution | |
| 30041HP | In distribution | ||
| 0032RA-12 | 12 | In distribution | |
| 0372RA-12 | 12 | In distribution | |
| 0143HP-12 | 12 | In distribution | |
| 20039RA-6 | 6 | In distribution | |
| 1251UM-100 | 100 | In distribution | |
| 0339RA-100 | 100 | In distribution | |
| 1423UM-50 | 50 | In distribution | |
| WC02-100 | 100 | In distribution | |
| 19039RA-100 | 100 | In distribution | |
| 1486SC-100 | 100 | In distribution | |
| 30036RA-6 | 6 | In distribution | |
| AS01.025FG-100 | 100 | In distribution | |
| R25010SO | In distribution | ||
| 0135RA-100 | 100 | In distribution | |
| 0733RA-12 | 12 | In distribution | |
| EM42-100 | 100 | In distribution | |
| 0223UM-100 | 100 | In distribution | |
| 1001UM-100 | 100 | In distribution | |
| 0320UM-100 | 100 | In distribution | |
| BRY0135RA-12 | 12 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kenda | DENT4YOU AG | 479 |
| Alpen | Coltene/Whaledent Gmbh & Co. KG | 234 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 211 |
| Jota | Jota AG | 86 |
| Wheel, Polishing Agent | Dentaurum GmbH & Co. KG | 34 |
| NTI | NTI-Kahla Gmbh, Rotary Dental Instruments | 22 |
| The Ultimate F & P Kit | GC America Inc. | 9 |
| Absolute Polishers™ | Parkell, Inc. | 7 |
| Jiffy Natural Universal | Ultradent Products Inc. | 7 |
| STARbrush | Ultradent Products Inc. | 5 |
| Polishers | DFS-Diamon Gmbh | 4 |
| 3M™ Sof-Lex™ | 3M Company | 4 |
Showing 12 of 29. All products under Wheel, Polishing Agent
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.