Alpen
Shapeguard Composite Plus Step 1 110ALPEN Polisher Wheel 230161UM
15manufacturers in China registered for this device type
234catalogue 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 | Coltene/Whaledent Gmbh & Co. KG, Germany |
|---|---|
| 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, Exporter |
| Premarket notification | Exempt |
| Record published | 2019-02-11 |
| Record revised | 2019-01-08 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2026-05-21 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| RL101558 | 50 | In distribution | |
| RP230387HP | 5 | In distribution | |
| RZ807F014FG | 5 | In distribution | |
| RL6055C018 | 50 | In distribution | |
| 60021907 | 5 | In distribution | |
| RP230315HP | 5 | In distribution | |
| RP230265RA | 5 | In distribution | |
| RZ807F016FG | 5 | In distribution | |
| RP230297RA | 5 | In distribution | |
| RP230375HP | 5 | In distribution | |
| RL707612 | 25 | In distribution | |
| RP230317RA | 5 | In distribution | |
| RZ889F010FG | 5 | In distribution | |
| RL707801 | 25 | In distribution | |
| RP230335RA | 5 | In distribution | |
| RP230355RA | 5 | In distribution | |
| RP230393RA | 5 | In distribution | |
| RP230267RA | 5 | In distribution | |
| RP231329HP | In distribution | ||
| RL101157 | 50 | In distribution | |
| 60021913 | 5 | In distribution | |
| RL100700 | 50 | In distribution | |
| RL862C014 | 50 | In distribution | |
| RP230059RA | 5 | In distribution | |
| RL839C012 | 50 | In distribution | |
| RL839F012 | 50 | In distribution | |
| RP230211RA | 5 | In distribution | |
| RL10170L | 50 | In distribution | |
| RL707714 | 25 | In distribution | |
| RP230055RA | 5 | In distribution | |
| XL856LSC018 | 100 | In distribution | |
| RL707406 | 25 | In distribution | |
| RL300004 | 50 | In distribution | |
| RP231399HP | In distribution | ||
| RL368C016 | 50 | In distribution | |
| RP230303RA | 5 | In distribution | |
| RP232004RA | 5 | In distribution | |
| RL300557 | 50 | In distribution | |
| 60021911 | 5 | In distribution | |
| RP230331RA | 5 | In distribution | |
| RP230205HP | 5 | In distribution | |
| 60021912 | 5 | In distribution | |
| RL300057 | 50 | In distribution | |
| RP230203RA | 5 | In distribution | |
| 60021906 | 5 | In distribution | |
| RZ856F025FG | 5 | In distribution | |
| RP230295RA | 5 | In distribution | |
| RL700EF4 | 25 | In distribution | |
| RP230194UM | 5 | In distribution | |
| RP230063RA | 5 | In distribution | |
| RL101171 | 50 | In distribution | |
| RL100556 | 50 | In distribution | |
| RP230329HP | 5 | In distribution | |
| RL200004 | 50 | In distribution | |
| RP231387HP | In distribution | ||
| RL852C012 | 50 | In distribution | |
| RL700EF6 | 25 | In distribution | |
| RL707902 | 25 | In distribution | |
| 60022205 | 5 | In distribution | |
| RL200002 | 50 | In distribution | |
| RP255049RA | 5 | In distribution | |
| 60021904 | 5 | In distribution | |
| RLKS1SC012 | 50 | In distribution | |
| RP230122RA | 5 | In distribution | |
| RL501557 | 50 | In distribution | |
| RL859C010 | 50 | In distribution | |
| RZ801LF014FG | 5 | In distribution | |
| RL100331 | 50 | In distribution | |
| RP230373HP | 5 | In distribution | |
| RL100332 | 50 | In distribution | |
| RP230347HP | 5 | In distribution | |
| XL85010F016 | 100 | In distribution | |
| RL707004 | 25 | In distribution | |
| RL707108 | 25 | In distribution | |
| RP230072RA | 5 | In distribution | |
| RP230136UM | 5 | In distribution | |
| RP232006RA | 5 | In distribution | |
| XL881C010 | 100 | In distribution | |
| RP230076RA | 5 | In distribution | |
| RL848C012 | 50 | In distribution | |
| RL500558 | 50 | In distribution | |
| RP230161UM | 5 | In distribution | |
| RL100245 | 50 | In distribution | |
| RP230357RA | 5 | In distribution | |
| RZ862F014FG | 5 | In distribution | |
| RL300056 | 50 | In distribution | |
| RP230313RA | 5 | In distribution | |
| RP230333HP | 5 | In distribution | |
| RP230291RA | 5 | In distribution | |
| RL837C014 | 50 | In distribution | |
| RZ885F012FG | 5 | In distribution | |
| RP230114RA | 5 | In distribution | |
| RP231363HP | In distribution | ||
| RL859F010 | 50 | In distribution | |
| RP230207RA | 5 | In distribution | |
| RP230369HP | 5 | In distribution | |
| XL801C016 | 100 | In distribution | |
| RL10702L | 50 | In distribution | |
| RP232002RA | 5 | In distribution | |
| RL707901 | 25 | In distribution | |
| RP230069RA | 5 | In distribution | |
| RL100558 | 50 | In distribution | |
| RP230215RA | 5 | In distribution | |
| RP230365HP | 5 | In distribution | |
| RP255047HP | 5 | In distribution | |
| RL707903 | 25 | In distribution | |
| RP230389HP | 5 | In distribution | |
| XL850C014 | 100 | In distribution | |
| RL100701 | 50 | In distribution | |
| RL707408 | 25 | In distribution | |
| RP230086RA | 5 | In distribution | |
| XL846RM016S | 100 | In distribution | |
| XL878KM012 | 100 | In distribution | |
| RL500004 | 50 | In distribution | |
| RL700EF9 | 25 | In distribution | |
| RL368C020 | 50 | In distribution | |
| RP230080RA | 5 | In distribution | |
| RP230353RA | 5 | In distribution | |
| RL100329 | 50 | In distribution | |
| RP230339RA | 5 | In distribution | |
| RP230327HP | 5 | In distribution | |
| XL855SC016S | 100 | In distribution | |
| RP230345HP | 5 | In distribution | |
| RL847F014 | 50 | In distribution | |
| RZ878KF021FG | 5 | In distribution | |
| XL828M026 | 100 | In distribution | |
| RL300331 | 50 | In distribution | |
| RP230293RA | 5 | In distribution | |
| XL862C012 | 100 | In distribution | |
| RL100330 | 50 | In distribution | |
| 60021910 | In distribution | ||
| RP230264RA | 5 | In distribution | |
| RP230395HP | 5 | In distribution | |
| RL100256 | 50 | In distribution | |
| RP230147RA | 5 | In distribution | |
| RL379F023 | 50 | In distribution | |
| RP230341HP | 5 | In distribution | |
| RP230213HP | 5 | In distribution | |
| RP230209HP | 5 | In distribution | |
| RL10700L | 50 | In distribution | |
| RP230186UM | 5 | In distribution | |
| RP231345HP | In distribution | ||
| RL379F018 | 50 | In distribution | |
| RL856LF018 | 50 | In distribution | |
| 60021905 | 5 | In distribution | |
| RP231397HP | In distribution | ||
| RP230361RA | 5 | In distribution | |
| RP230134UM | 5 | In distribution | |
| RL10169L | 50 | In distribution | |
| RP231385HP | In distribution | ||
| RL707664 | 25 | In distribution | |
| RL40330G | 50 | In distribution | |
| XL392F016 | 100 | In distribution | |
| RP230325RA | 5 | In distribution | |
| XL392M016 | 100 | In distribution | |
| XL801C023 | 100 | In distribution | |
| RP230299RA | 5 | In distribution | |
| RP230201RA | 5 | In distribution | |
| RP230379RA | 5 | In distribution | |
| RL860C014 | 50 | In distribution | |
| RP230399HP | 5 | In distribution | |
| RP230337RA | 5 | In distribution | |
| RP230371HP | 5 | In distribution | |
| RP230363HP | 5 | In distribution | |
| RP230367HP | 5 | In distribution | |
| RL100246 | 50 | In distribution | |
| RP230351HP | 5 | In distribution | |
| RP230305RA | 5 | In distribution | |
| RZ801F022FG | 5 | In distribution | |
| RL858C012 | 50 | In distribution | |
| RP230391RA | 5 | In distribution | |
| RL862C010 | 50 | In distribution | |
| XL837C016 | 100 | In distribution | |
| RL707006 | 25 | In distribution | |
| RLKS1SC012FG | 50 | In distribution | |
| RP231327HP | In distribution | ||
| RP231347HP | In distribution | ||
| RL101557 | 50 | In distribution | |
| XL85010SC016 | 100 | In distribution | |
| RP230271RA | 5 | In distribution | |
| RP230159UM | 5 | In distribution | |
| XL801C018 | 100 | In distribution | |
| RP230196UM | 5 | In distribution | |
| RL909406 | 50 | In distribution | |
| RP230359HP | 5 | In distribution | |
| RL500002 | 50 | In distribution | |
| XL845RM018 | 100 | In distribution | |
| RZ801LF012FG | 5 | In distribution | |
| RL100169 | 50 | In distribution | |
| RP230397HP | 5 | In distribution | |
| RL500702 | 50 | In distribution | |
| RP230180UM | 5 | In distribution | |
| XL368C016 | 100 | In distribution | |
| RL300002 | 50 | In distribution | |
| XL862F010 | 100 | In distribution | |
| RL905F027 | 50 | In distribution | |
| XL845RM025 | 100 | In distribution | |
| RL135F014 | 50 | In distribution | |
| RL100170 | 50 | In distribution | |
| XL10839M016 | 100 | In distribution | |
| RL100557 | 50 | In distribution | |
| RL856C018 | 50 | In distribution | |
| 60022206 | 5 | In distribution | |
| RP230323HP | 5 | In distribution | |
| RL846RC016 | 50 | In distribution | |
| 60022207 | 2 | In distribution | |
| RL905F031 | 50 | In distribution | |
| RP230139RA | 5 | In distribution | |
| RL879KC016 | 50 | In distribution | |
| RP230301RA | 5 | In distribution | |
| RL856L9C014 | 50 | In distribution | |
| RL500556 | 50 | In distribution | |
| RP230381RA | 5 | In distribution | |
| RP230385HP | 5 | In distribution | |
| RP231365HP | In distribution | ||
| RL859C018 | 50 | In distribution | |
| RP230319RA | 5 | In distribution | |
| RL200008 | 50 | In distribution | |
| RL8605C012 | 50 | In distribution | |
| RL859EF014 | 50 | In distribution | |
| RP230188UM | 5 | In distribution | |
| RZ856F018FG | 5 | In distribution | |
| RP230377HP | 5 | In distribution | |
| RP230321RA | 5 | In distribution | |
| RP230383HP | 5 | In distribution | |
| XL847SC016 | 100 | In distribution | |
| 60021904 | In distribution | ||
| RP230349RA | 5 | In distribution | |
| RL707404 | 25 | In distribution | |
| XL379SC023 | 100 | In distribution | |
| W40199ZC | 100 | In distribution | |
| RP230343RA | 5 | In distribution | |
| RL500557 | 50 | In distribution | |
| XL848SC016 | 100 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Edenta | Edenta Etablissement | 1,065 |
| Kenda | DENT4YOU AG | 479 |
| 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.