Porcelain & Enamel Polishing KIT CA
Contains DIs: E235253A0; E235256A0; E235259A0; E235251A0; E235254A0; E235257A0;E23502530; E23502560; E23502230; E23502280
9manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Hebei (2), Henan (2), Shanghai (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Xinwell Medical Technology Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 12 |
| Huanghua Promisee Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 54 |
| Anqing Clean Dental Instrument Technology Co., Ltd. | Anqing | Anhui | Manufacturer | 50 |
| Henan Baistra Medical Devices Limited | Zhengzhou | Henan | Manufacturer | 34 |
| Tangshan Zhengtong Exhibition Co., Ltd. | Tangshan | Hebei | Manufacturer | 34 |
| Gavin Biotechnology Co., Ltd. | Jinzhong | Shanxi | Manufacturer | 16 |
| Henan Lusterdent Medical Instrument Co., Ltd. | Zhengzhou | Henan | Manufacturer | 15 |
| Shanghai Toboom Dental Techonology Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Shanghai Shofu Dental Material Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
Record
| Listed by | Shofu Dental Corp., United States |
|---|---|
| FDA product code | EHL |
| Device type | Point, Abrasive |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6010 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2021-07-20 |
| Record revised | 2022-10-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Storage | Storage environment temperature 1 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0317B | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Brasseler USA | Peter Brasseler Holdings, LLC | 313 |
| Point, Abrasive | Hager & Meisinger Gesellschaft mit beschränkter Haftung | 265 |
| Jazz Polisher | SS White Burs LLC | 128 |
| Sunshine Diamonds | DR. Hopf Gmbh & Co. KG | 125 |
| Horico | Hopf, Ringleb & Co. Gmbh & CIE. | 122 |
| Komet Abrasive Instruments | Gebr. Brasseler Gmbh & Co. KG | 101 |
| Polishers | DFS-Diamon Gmbh | 101 |
| Dura-Green | Shofu Dental Corp. | 94 |
| Busch®, BNA® | Busch & Co. GmbH & Co. KG | 85 |
| MDT Dental Polishers | M.D.T. – Micro Diamond Technologies Ltd. | 81 |
| Henry Schein | Henry Schein, Inc. | 75 |
| Jota | Jota AG | 68 |
Showing 12 of 173. All products under Point, Abrasive
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.