Miscellaneous devices · 21 CFR 872 Subpart G
Prophylaxis Cup
FDA device type “Cup, Prophylaxis”.
- Companies listing it
- 11975 makers
- Brands and models
- 165
- 510(k) clearances
- 80 in five years
- FDA name
- Cup, Prophylaxis
510(k) clearances per year, 1976–2026
Companies that list EHK
119 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | — | 148 | 2026 |
| Premier Dental Products Company | United States | Maker | Premier® 2pro® Disposable Prophy Angle · Premier® ProFlare Disposable Prophy Angle | 28 | 2026 |
| Young Innovations Inc | United States | Maker | BRUSHES AND POLISHERS · DISPOSABLE PROPHYLAXIS CUPS · Prpphy Angles | 23 | 2025 |
| Pac-Dent Inc. | United States | Maker | AntiSplatr Disposable Prophy Angles | 5 | 2022 |
| Premium Plus (Dongguan) Limited | China | Maker | Disposable Prophy Brushes · Disposable Prophy Cups | 2 | 2025 |
| Lakong Medical Devices Co., Ltd. | China | Maker | disposable rubber cup · Prophylaxis, cups, brushes and angles | 2 | 2026 |
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | PROPHY ANGLES | 1 | 2025 |
| Pacific Care Limited | Hong Kong SAR China | Maker | Sunstar Butler, Inc. | 1 | 2025 |
| Angelus Industria DE Produtos Odontologicos S/A | Brazil | Maker | Angie Prophy | 11 | 2021 |
| Hu-Friedy Mfg Co., LLC | United States | Maker | Hu-Friedy Mfg Co.,LLC · Pumice Cup | 8 | 2012 |
| Micerium S.P.A. | Italy | Maker | Ena Oral Care Smart Prophy Brushes and Polishers | 6 | 2011 |
| Dxm Co., Ltd. | South Korea | Maker | DPA110 · Multiple names | 6 | 2020 |
| Rolence Ent., Inc. | Taiwan | Maker | PROPHY ANGLE | 5 | 2009 |
| Premium Plus International Limited | Hong Kong SAR China | Maker | Dentmas · S-251 Prophy Cups, Screw-In · S-M252 Prophy Cups, RA, Metal Shank · T-251 Prophy Cups, Screw-In · +6 | 3 | 2017 |
| Preventive Technologies, Inc. | United States | Maker | PIVOT DISPOSABLE PROPHY ANGLE | 3 | 2014 |
| Sunstar Americas, Inc. | United States | Maker | BUTLER · DUROPRO · EEZ-TOUCH · MONSTERZ · +1 | 2 | 2013 |
| Abrasive Technology, Inc. | United States | Maker | APPLICATORS · MANDRELS | 1 | 1990 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | alcohol lamp · CUP,PROPHYLAXIS · dental brush / prophylactic brush · dental cup · +6 | — | — |
| Shenzhen Denco Medical Co Ltd | China | Maker | PROPHY ANGLES | — | — |
| TDV Dental Ltda | Brazil | Maker | PROFILAX · Prophy Brushes | — | — |
| Huanghua Promisee Dental Co., Ltd | China | Maker | Prophy brush · Prophy cup | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | CUP, PROPHYLAXIS | — | — |
| Shanghai Alwings Medical Instrument Co.,Ltd. | China | Maker | Paper Cup · Plastic Cup · Prophy Angles · Prophy Brush · +1 | — | — |
| Shanghai Dochem Industries Co., Ltd. | China | Maker | Prophy Brush · Prophy Cup | — | — |
| Shanghai Jolly Industrial Co., Ltd. | China | Maker | Cup, prophylaxis · Prophy angle · Prophy brush, prophy cup | — | — |
| Shanghai Lions Industrial Co., Ltd. | China | Maker | cup, prophylaxis · Prophy angle · Prophy brush, prophy cup | — | — |
| Adolf Schweick Hardt GmbH & Co | Germany | Maker | CUP, PROPHYLAXIS | — | — |
| Beyes Dental Inc | Canada | Maker | easyProphy Disposable Angles and Cups | — | — |
| Tangshan Zhengtong Exhibition Co., Ltd. | China | Maker | Disposable Prophy Angles, Disposable Prophy Cups · Prophy Angles, Prophy Cups · Prophy Brushes | — | — |
| ZOGEAR Medical Co., Ltd. | China | Maker | CUP, PROPHYLAXIS | — | — |
| Anqing Clean Dental Instrument Technology Co Ltd | China | Maker | dental polishing brush/ polishing kits | — | — |
| Hubei Guarddent Medical Technology Co.,Ltd | China | Maker | Prophy angle/cup/brush | — | — |
| BH Medical Products Co., Ltd | China | Maker | Prophy cup | — | — |
| Jiangsu Yabaobao Medical Instrument Co.,Ltd. | China | Maker | Dappen dish,glass,plastic Glass mortar & pestle Alcohol lamp No-stick mixing cup | — | — |
| READY SET IMPORT dba Mynt Professional | United States | Maker | RSI Prophy Angles | — | — |
| TF New Material Sci and Tec Co.,ltd | China | Maker | Cup · Plastic Cup · Polish brush · Prophy angle | — | — |
| Hefei Xingcheng Sanitary Products CO.,LTD | China | Maker | Disposable Prophy Angle, Prophy cup, Prophy brush | — | — |
| Onvet Medical Canada Inc. | Canada | Maker | Glacier® Angles and Cups | — | — |
| Henan Lusterdent Medical Instrument Co.,Ltd | China | Maker | Prophy Brushes and Cups | — | — |
| CDM Center of Excellence Ltd. | China | Maker | Cup, Prophylaxis | — | — |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | China | Maker | Prophy Cup Brush | — | — |
| Boen Healthcare Co Ltd | China | Maker | Prophylaxis Cup; Prophy Cup | — | — |
| Erskine Dental | Australia | Maker | Superdaps, Plastic Dappen Dish, Mixing Well, Brush Holder | — | — |
| Xiantao S&J Protective Products Co., Ltd | China | Maker | Prophy Cup; Prophy Brush; Prophy Angles, Dappen Dishes | — | — |
| Hefei Mlush Sanitary Products Co., Ltd | China | Maker | polish brush/cup/ prophy angle | — | — |
| Dongguan Wanjin Industrial Co., Ltd | China | Maker | CUP | — | — |
| Guangzhou Four E's Scientific Co., Ltd. | China | Maker | Prophylaxis Cup | — | — |
| Nawaz and Sons | Pakistan | Maker | EHK / CUP, PROPHYLAXIS | — | — |
| Wellmed Dental Medical Supply Co., Ltd. | China | Maker | CUP, PROPHYLAXIS | — | — |
| Cordica Medical (Formally Team Technologies, Inc) | United States | Maker | — | — | — |
| Jiangsu Province Yangzhou Shuguang Toothbrush Manu | China | Maker | Prophy Brush | — | — |
| Zhejiang Mediunion Healthcare Group Co Ltd | China | Maker | dental cup | — | — |
| ASA Dental | Italy | Maker | DAPPEN DISHES | — | — |
| Yongqing Huaguan Dental Instruments Factory | China | Maker | dental mixing well | — | — |
| Hefei Jingcheng Plastic Products Co. Ltd | China | Maker | Disposable Prophy Angles | — | — |
| Anhui JM Healthcare Products Co.,Ltd. | China | Maker | CUP, PROPHYLAXIS,Prophy Cup Brush,prophy angle | — | — |
| Dhef Inc. | Taiwan | Maker | CUP · PROPHYLAXIS | — | — |
| Yueying Medical Instruments (Langfang) Co., Ltd. | China | Maker | Dental Mixing Well | — | — |
| Anhui Ares Medical Technology Co.,Ltd. | China | Maker | prophy angle | — | — |
| Changzhou Shengkang Medical Instrument Co.,LTD | China | Maker | Polishing brush | — | — |
| Dongguan Yilong Medical Supplies Co., Ltd. | China | Maker | Prophy Angle, Prophy Brush, Prophy Cup | — | — |
| Dongguan Ouwen Medical Device Technology Co., Ltd. | China | Maker | Prophy Cup; Prophy Brush | — | — |
| Weihai Xingtai Packaging Products Co., Ltd. | China | Maker | Prophy angle | — | — |
| Reco-Dent International Co., Ltd. | Taiwan | Maker | Prophylaxis Cup | — | — |
| Huizhou Hizorion Tech Co.,Ltd | China | Maker | BW-HW-CP · Mug or Cup.---BW-HW-MG,Sl.-HW-MG,ST-HW-MG | — | — |
| Jiangsu JianYu Health Medical Co., Ltd | China | Maker | Prophylaxis Cup | — | — |
| Jung Chen Technology Co., Ltd | China | Maker | Disposable Prophy Angle | — | — |
| Cole Instruments | United States | Maker | Ring Cup 2-pocket | — | — |
| Guangzhou FuZelong Hygiene Material Co Ltd | China | Maker | PUYUAN | — | — |
| Dentex Dental Industrial Corp | Taiwan | Maker | — | — | — |
| Helmut Zepf Medizintechnik GmbH | Germany | Maker | — | — | — |
| Oogie Solutions LLC | United States | Maker | — | — | — |
| Proguard Health Inc. | United States | Maker | — | — | — |
| Stoddard MFG. Co., Ltd. | United Kingdom | Maker | — | — | — |
| Track of Surgical | Pakistan | Maker | — | — | — |
| Ultradent Products, Inc. | United States | Contract manufacturer | Opal Cups, Bristle · Opal Cups, Finishing | 95 | 2026 |
| Cosmedent, Inc. | United States | Repacker / relabeler | FlexiCups | 27 | 2024 |
| Keystone Industries | United States | Contract manufacturer | Keystone Industries Prophy Cup · Prehma Prophylaxis Cups · Prehma Prophylaxis Polishing Brushes | 2 | 2025 |
| W&H Dentalwerk Buermoos GmbH | Austria | Contract manufacturer | — | 17 | 2026 |
| Reliance Orthodontic Products, Inc. | United States | Contract manufacturer | PREP STEP DISPOSABLE PROPHY ANGLE | 32 | 2021 |
| Dentamerica | United States | Repacker / relabeler | DENTAMERICA | 4 | 2010 |
| Tpc Advanced Technology, Inc. | United States | Repacker / relabeler | TPC Disposable Prophy Cup | 3 | 2007 |
| Hager Worldwide, Inc. | United States | Manufacturer | Hager Prophy Angles · Hager Prophy Brushes · Rotoprox | 2 | 2005 |
| Directa AB | Sweden | Contract manufacturer | ProphyCare ProphyCup | 1 | 2015 |
| One Dashcorp | United States | Repacker / relabeler | Valdent USA Disposable Prophy Cups, Latch Type, 4 Leaves, White, Soft Silicone · Valdent USA Disposable Prophy Cups, Latch Type, 6 Leaves, White, Soft Silicone · Valdent USA Prophy Brush, Latch Type, White | — | — |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | dental prophy brush · DISPOSABLE PROPHY BRUSH · POLISHING BRUSH · prophy angle · +3 | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | TORINO | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Disposable Prophy Angle | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | Prophy Angles; Prophy Brushes; Prophy Cups; Disposable Prophy Angles; Disposable Prophy Cups | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson Prophy Cups | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | Cup | — | — |
| Aspen Surgical Products | United States | Contract manufacturer | Symmetry Surgical | — | — |
| Premium Plus Dental | United States | Lister | Densco Prophy Cups,Brushes · Premium Plus Prophy Cups | — | — |
| Pascal International | United States | Contract manufacturer | Contra Angle · Prophy Angle | — | — |
| Yizur Ltd | Hong Kong SAR China | Foreign exporter | Prophy Angle | — | — |
| LLD Care d.o.o. | Croatia | Foreign exporter | Glitter, Paste Cups | — | — |
| Bioclear Matrix Systems, LLC | United States | Repacker / relabeler | Magic Mix Cups | — | — |
| Maxill Inc. | United States | Foreign exporter | Maxill | — | — |
| Shanghai MU PROMOTIONS Co., Ltd. | China | Foreign exporter | Dappen Dish,Glass,Plastic Glass Mortar & Pestle Alcohol Lamp No-Stick Mixing Cup | — | — |
| Shanghai smedent medical instrument co., ltd. | China | Foreign exporter | prophy angle ,prophy brush, prophy cup, prophy point | — | — |
| ATOMO Dental, Inc. | United States | Repacker / relabeler | Prophy Angles; Prophy Brushes; Prophy Cups; Disposable Prophy Angles; Disposable Prophy Cups | — | — |
| Dental Brands for Less | Canada | Foreign exporter | DENTSPLY | — | — |
| Dukal Corporation | United States | Specification developer | Unipack Prophy Angles | — | — |
| W&H Impex Inc. | Canada | Foreign exporter | — | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| O&S Dental Inc | United States | Manufacturer for export | — | — | — |
| Oriental International Supplies Limited | Hong Kong SAR China | Foreign exporter | Prophy Brush | — | — |
| Peter Brasseler Holdings, LLC | United States | Contract manufacturer | — | — | — |
| HEXA Dental | United States | Contract manufacturer | — | — | — |
| CWGC LA Inc. | United States | Repacker / relabeler | Drinking Paper Cup, 3 oz., White Color 100 cups/bag, 50 bags/CS = 5,000 cups/case (Model AMC3 PA) · Drinking Paper Cup, 7 oz., White Color 100 cups/bag, 20 bags/CS = 2,000 cups/case (Model AMC7 PA) · Paper Portion Container, 3.5 oz, White Color 100 cups/bag, 50 bags/CS = 5,000 cups/case (Model AMC3 5PA) · Plastic Cup, 1 oz., Transparency Color, 100 cups/bag, 50 bags/CS = 5,000 cups/case (Model AMC1 PL) | — | — |
| Kash Sales Inc. | Canada | Foreign exporter | — | — | — |
| New Pentastar Medical Products Co. Limited | Hong Kong SAR China | Foreign exporter | Dental cup, Denture Cup | — | — |
| Olulo LLC | United States | Repacker / relabeler | — | — | — |
| PacStar International, inc. | United States | Repacker / relabeler | Angle cup | — | — |
| Rece International Corp. | United States | Repacker / relabeler | VIAMED PROPHYLAXIS(DENTAL)CUP | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
| Bright Supply Inc | United States | Lister | — | — | — |
| AD Supply Group Limited | United Kingdom | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 29 Sep 1995 | K953628 | PROPHY ANGLE | Rolence Enterprise, Inc. |
| 2 May 1995 | K951016 | DISPOSABLE PROPHYLAXIS ANGLE | Preventive Technologies, Inc. |
| 10 Apr 1990 | K900507 | DISPOSABLE SCREW TYPE PROPHY BRUSH | Dentsply Intl., Inc. |
| 19 Nov 1986 | K864059 | DENTAL PROPHY CUPS (VARIOUS TYPES) | Mission White Dental, Inc. |
| 8 Jan 1981 | K803155 | PROPHYLAXIS CUP. | Teledyne Densco |
| 15 Jun 1979 | K790723 | PROPHYLAXIS CUPS AND POLISHERS | Young Innovations Inc |
| 16 Feb 1978 | K780198 | PROPHY CUPS, R&R | Ransom & Randolph. LLC. |
| 24 Mar 1977 | K770556 | PRO-KUP | Dental Control Products |
Official records: FDA product classification for EHK · 21 CFR 872.6290.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026