Instruments for functional explorations and therapeutic interventionsDental stomatology instrumentsVarious dental stomatology instruments
Dental prophylaxis equipment
EMDN code Z12119007
Manufacturers registered in Europe (EUDAMED) 7
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a manufacturer to see its full range, a model to open its EUDAMED record.
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Other manufacturers known in the United States (FDA) 24
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| E.M.S Electro Medical Systems S.A Present in Europe in other categories | United States | AIR-FLOW AIR-FLOW-PIEZON GBT Machine Wireless Pedal GBT FLOWCONTROL x 4 GBT Machine Station Boost wireless pedal | registered |
| RELIANCE ORTHODONTIC PRODUCTS INC | United States | ETCHMASTER ASK ALL SURFACE KIT | registered |
| Deldent , Ltd. | Israel | JETPOLISHER 2000 JP/JST/JS HANDPIECE MB coupling Midwest JETSTREAM Miniblaster Nozzle Extension MB Quick coupling Sirona | K014252 (2002) |
| GROMAN INC. | United States | Etchmaster | K030292 (2003) |
| HU-FRIEDY MFG. CO., LLC | United States | HuFriedyGroup PWR Handpiece Subgingival PWR Perio Tips PWR Air PWR Pair | registered |
| Young Innovations, Inc. | United States | Johnson-Promident | registered |
| DANVILLE MATERIALS, LLC | United States | MICROETCHER PREPSTART PREPAIR | K033215 (2004) |
| Guilin Woodpecker Medical Instrument Co., Ltd. Present in Europe in other categories | China | DTE woodpecker LOVE HYGIENE | registered |
| HENRY SCHEIN, INC. Present in Europe in other categories | United States | Henry Schein | K862384 (1986) |
| BENCO DENTAL SUPPLY CO. | – | MINIBLASTER | registered |
| Crystalmark Dental Systems, Inc. | United States | CRYSTALAIR | registered |
| Dentsply Professional | – | Cavitron® | registered |
| MEDIVANCE INSTRUMENTS LIMITED | United Kingdom | Velopex AquaCut Fluid Abrasion Unit | registered |
| Rønvig Dental Manufacturing A/S | – | DENTO PREP | registered |
| YOUNG DENTAL MANUFACTURING I, LLC | – | Johnson-Promident | registered |
| DENTAL TECHNOLOGIES, INC. | United States | – | registered |
| DENTSPLY SIRONA INC | United States | – | registered |
| Dell Dent Ltd. | Israel | – | registered |
| LLD Care d.o.o. | Croatia | – | registered |
| Mainline Medical Dental Supply | Canada | – | registered |
| Mectron S.P.A. Present in Europe in other categories | Italy | – | K251425 (2025) |
| Parkell, Inc. Present in Europe in other categories | United States | – | K973679 (1998) |
| RONVIG DENTAL MFG. A/S | Denmark | – | registered |
| Zest Anchors, LLC | United States | – | registered |
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