Jazz Polisher
Jazz HP Zirconia/Lithium Disilicate Polisher 3 Step ZL32 Coarse Wheel Unmounted Shank - 1 Pack
9manufacturers in China registered for this device type
128catalogue numbers in this listing
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 | SS White Burs LLC, United States |
|---|---|
| FDA product code | EHL |
| Device type | Point, Abrasive |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6010 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-02-19 |
| Record revised | 2025-05-22 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| U89018B | 25 | In distribution | |
| U89159 | 3 | In distribution | |
| U89008 | 25 | In distribution | |
| U89015 | 3 | In distribution | |
| U89118 | 3 | In distribution | |
| U89037B | 25 | In distribution | |
| U89140 | In distribution | ||
| U89007 | 3 | In distribution | |
| U89163 | 3 | In distribution | |
| U89123 | 3 | In distribution | |
| U89038 | 20 | In distribution | |
| U89152 | In distribution | ||
| U89005 | 3 | In distribution | |
| U89036 | 20 | In distribution | |
| U89164 | 3 | In distribution | |
| U89198 | 6 | In distribution | |
| U89004 | 3 | In distribution | |
| U89134 | 3 | In distribution | |
| U89156 | 3 | In distribution | |
| U89011 | 3 | In distribution | |
| U89168 | 5 | In distribution | |
| U89191 | 6 | In distribution | |
| U89153 | In distribution | ||
| U89023 | 3 | In distribution | |
| U89150 | 3 | In distribution | |
| U89022 | 3 | In distribution | |
| U89111 | 3 | In distribution | |
| U89112 | 3 | In distribution | |
| U89111 | 3 | In distribution | |
| U89136 | In distribution | ||
| U89161 | In distribution | ||
| U89034 | 3 | In distribution | |
| U89184 | 4 | In distribution | |
| U89193 | 6 | In distribution | |
| U89026 | 3 | In distribution | |
| U89004 | 25 | In distribution | |
| U89125 | 3 | In distribution | |
| U89160 | 3 | In distribution | |
| U89138 | 3 | In distribution | |
| U89010 | 3 | In distribution | |
| U89017B | 25 | In distribution | |
| U89141 | In distribution | ||
| U89124 | 3 | In distribution | |
| U89116 | 3 | In distribution | |
| U89137 | In distribution | ||
| U89012 | 3 | In distribution | |
| U89155 | 3 | In distribution | |
| U89014 | 3 | In distribution | |
| U89189 | 6 | In distribution | |
| U89181 | 3 | In distribution | |
| U89110 | 3 | In distribution | |
| U89031 | 3 | In distribution | |
| U89113 | 3 | In distribution | |
| U89033 | 3 | In distribution | |
| U89019B | 25 | In distribution | |
| U89146 | 3 | In distribution | |
| U89006 | 3 | In distribution | |
| U89154 | In distribution | ||
| U89025 | 3 | In distribution | |
| U89125 | 3 | In distribution | |
| U89188 | 5 | In distribution | |
| U89116 | 3 | In distribution | |
| U89151 | 3 | In distribution | |
| U89144 | In distribution | ||
| U89142 | 3 | In distribution | |
| U89196 | 6 | In distribution | |
| U89117 | 3 | In distribution | |
| U89033 | In distribution | ||
| U89020B | 25 | In distribution | |
| U89009 | 3 | In distribution | |
| U89028 | 3 | In distribution | |
| U89117 | 3 | In distribution | |
| U89186 | 3 | In distribution | |
| U89149 | In distribution | ||
| U89190 | 6 | In distribution | |
| U89183 | 5 | In distribution | |
| U89115 | 3 | In distribution | |
| U89033 | In distribution | ||
| U89182 | 5 | In distribution | |
| U89197 | 6 | In distribution | |
| U89017 | 20 | In distribution | |
| U89158 | In distribution | ||
| U89135 | 3 | In distribution | |
| U89036 | In distribution | ||
| U89037 | 20 | In distribution | |
| U89113 | 3 | In distribution | |
| U89122 | 3 | In distribution | |
| U89027 | 3 | In distribution | |
| U89012 | 25 | In distribution | |
| U89148 | In distribution | ||
| U89192 | 6 | In distribution | |
| U89018 | 20 | In distribution | |
| U89013 | 3 | In distribution | |
| U89165 | 6 | In distribution | |
| U89124 | 3 | In distribution | |
| U89119 | 3 | In distribution | |
| U89031 | In distribution | ||
| U89114 | 3 | In distribution | |
| U89019 | 20 | In distribution | |
| U89120 | 3 | In distribution | |
| U89185 | 3 | In distribution | |
| U89147 | 3 | In distribution | |
| U89115 | 3 | In distribution | |
| U89118 | 3 | In distribution | |
| U89020 | 20 | In distribution | |
| U89157 | In distribution | ||
| U89121 | 3 | In distribution | |
| U89180 | 3 | In distribution | |
| U89187 | 3 | In distribution | |
| U89122 | 3 | In distribution | |
| U89194 | 6 | In distribution | |
| U89143 | 3 | In distribution | |
| U89031 | In distribution | ||
| U89036B | 25 | In distribution | |
| U89008 | 3 | In distribution | |
| U89024 | 3 | In distribution | |
| U89145 | In distribution | ||
| U89110 | 3 | In distribution | |
| U89112 | 3 | In distribution | |
| U89166 | 6 | In distribution | |
| U89121 | 3 | In distribution | |
| U89162 | In distribution | ||
| U89195 | 6 | In distribution | |
| U89029 | 3 | In distribution | |
| U89167 | 6 | In distribution | |
| U89032 | 3 | In distribution | |
| U89133 | In distribution | ||
| U89139 | 3 | 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 |
| 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 |
| Johnson-Promident | Young Innovations Inc. | 37 |
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.