Absolute Polishers™
Absolute Polishers™; Point Smoothers (non-diamond)
15manufacturers in China registered for this device type
7catalogue 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 | Parkell, Inc., United States |
|---|---|
| FDA product code | EJQ |
| Device type | Wheel, Polishing Agent |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6010 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-08-02 |
| Record revised | 2023-12-25 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store in cool, dark, dry-humidity environment; Storage environment temperature 2 to 28 °C |
| Distribution end date | 2020-11-30 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| S082 | 24 | Withdrawn | |
| S081 | 24 | Withdrawn | |
| S084 | 12 | Withdrawn | |
| S086 | Withdrawn | ||
| S085 | 12 | Withdrawn | |
| S080 | 24 | Withdrawn | |
| S083 | 24 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Edenta | Edenta Etablissement | 1,065 |
| 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 |
| 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.