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Sign in to claim this brandDent4You AG
Switzerland·CH-MF-000028926
Last updated September 17, 2026
What Dent4You AG makes
Dent4You AG manufactures reusable dental burs (diamond and carbide), silicone impression materials, dental abrasive points, and composite resins for restorative procedures. Their portfolio also includes dental sterilization equipment, such as chemical/thermal surgical instrument washers, ultrasonic scaling systems, and steam sterilizers. Specific products include composite resin kits like ParaCore and PRESIDENT, as well as adhesive materials and impression putties.
The company’s devices are classified under EU Medical Device Regulations as Class I, Class II, and Class IIa, with listings in the EUDAMED database and the FDA’s UDI system. Dent4You AG is based in Switzerland.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Dent4You AG manufacture?
Dent4You AG specializes in dental medical devices, including reusable tools like diamond and carbide dental burs, dental abrasive points, and sterilization equipment such as chemical/thermal surgical instrument washers, ultrasonic scaling systems, and steam sterilizers. They also produce consumable materials like silicone dental impression materials and dental composite resins (e.g., ParaCore and PRESIDENT kits) used for restorative dental procedures.
Where is Dent4You AG based, and what region does it serve?
Dent4You AG is headquartered in Switzerland (CH). While the company’s exact market reach isn’t specified, its devices are listed in the EUDAMED database and the FDA’s UDI system, indicating compliance with European and U.S. regulatory requirements. This suggests its products are designed for global dental professionals, though distribution channels would depend on local partners or direct sales.
Which regulatory registries list Dent4You AG’s devices?
Dent4You AG’s devices are listed in two key regulatory databases: EUDAMED (the European Union’s medical device registry) and the FDA’s UDI (Unique Device Identification) system in the U.S. These listings help healthcare providers and regulators verify the manufacturer and traceability of specific devices, ensuring compliance with EU MDR and U.S. FDA requirements.
How are Dent4You AG’s devices classified under EU regulations?
Under the EU Medical Device Regulations (MDR), Dent4You AG’s devices fall into Class I, Class II, and Class IIa classifications. The classification depends on factors like risk level, intended use, and interaction with the patient (e.g., reusable burs or sterilization equipment are typically higher risk than consumable resins). Class IIa devices, for example, may require additional conformity assessments due to moderate risks, while Class I items (like some impression materials) have lower regulatory scrutiny but still require compliance with essential safety requirements.
What distinguishes Dent4You AG’s reusable dental tools from single-use alternatives?
Dent4You AG offers reusable dental burs (diamond and carbide) and abrasive points, which are designed for durability and repeated use after proper sterilization (e.g., via their chemical/thermal washers or steam sterilizers). Unlike single-use tools, these require maintenance (cleaning, disinfection, or sharpening) but reduce waste and costs over time. Their classification as reusable devices also influences regulatory pathways, as they must meet stricter safety and sterilization standards compared to disposable alternatives.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Switzerland
- Address
- 2, Bahnhofstr. , Heerbrugg, Switzerland
- Website
- coltene.com
- —
- —
- [email protected]
- Phone
- +41717575300
- PRRC Contact
- Kelly Makimoto
- EUDAMED SRN
- CH-MF-000028926
- FDA FEI Number
- 3022516928
- DUNS Number
- 480152811
Catalogue (2186)
Page 18 of 44| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Speedex | 4970 EM | EUDAMEDFDA UDI | Class II | Active |
| DIATECH Diamonds | 60032316 | FDA UDI | Class I | Active |
| Kenda | 0239.025 | FDA UDI | Class I | Active |
| Alpen Diamonds | 60032539 | FDA UDI | Class I | Active |
| DIATECH Diamonds | 60032148 | FDA UDI | Class I | Active |
| Alpen Carbides | R707714 | FDA UDI | Class I | Active |
| Alpen Carbides | R707642 | FDA UDI | Class I | Active |
| Alpen Diamonds | 60032535 | FDA UDI | Class I | Active |
| Alpen Carbides | R101558C | FDA UDI | Class I | Active |
| Alpen Diamonds | 60032730 | FDA UDI | Class I | Active |
| Alpen Carbides | R200006C | FDA UDI | Class I | Active |
| BRAVO G4 Chamber Autoclave | 7A620030 | FDA UDI | Class II | Active |
| PRESIDENT The Original | 60022166 | EUDAMEDFDA UDI | Class II | Active |
| DIATECH Diamonds | 60031916 | FDA UDI | Class I | Active |
| Kenda | 0233.012 | FDA UDI | Class I | Active |
| Alpen Diamonds | 60031989 | FDA UDI | Class I | Active |
| DIATECH Diamonds | 60031950 | FDA UDI | Class I | Active |
| Alpen Diamonds | 60032159 | FDA UDI | Class I | Active |
| Alpen Diamonds | 60032147 | FDA UDI | Class I | Active |
| Alpen Diamonds | 60032725 | FDA UDI | Class I | Active |
| Alpen Carbides | R100330 | FDA UDI | Class I | Active |
| Alpen Diamonds | 60031778 | FDA UDI | Class I | Active |
| PRESIDENT The Original | 60022173 | EUDAMEDFDA UDI | Class II | Active |
| Alpen Carbides | R101170 | FDA UDI | Class I | Active |
| DIATECH Diamonds | 60032170 | FDA UDI | Class I | Active |
| DIATECH Diamonds | 60032368 | FDA UDI | Class I | Active |
| Alpen Diamonds | 60032453 | FDA UDI | Class I | Active |
| DIATECH Diamonds | 60031912 | FDA UDI | Class I | Active |
| DIATECH Diamonds | 60032616 | FDA UDI | Class I | Active |
| DIATECH Diamonds | 60031804 | FDA UDI | Class I | Active |
| DIATECH Diamonds | 60032190 | FDA UDI | Class I | Active |
| Alpen Diamonds | 60032229 | FDA UDI | Class I | Active |
| Alpen Diamonds | 60031835 | FDA UDI | Class I | Active |
| DIATECH Diamonds | 60032678 | FDA UDI | Class I | Active |
| Alpen Diamonds | 60032109 | FDA UDI | Class I | Active |
| BRAVO G4 Chamber Autoclave | 7A621030 | FDA UDI | Class II | Active |
| Alpen Diamonds | 60032049 | FDA UDI | Class I | Active |
| DIATECH Diamonds | 60032138 | FDA UDI | Class I | Active |
| DIATECH Diamonds | 60031960 | FDA UDI | Class I | Active |
| Alpen Diamonds | 60032105 | FDA UDI | Class I | Active |
| DIATECH Diamonds | 60032194 | FDA UDI | Class I | Active |
| Alpen Carbides | R100035C | FDA UDI | Class I | Active |
| Affinis | 6685 | FDA UDI | Class II | Active |
| DIATECH Diamonds | 60032240 | FDA UDI | Class I | Active |
| Alpen Diamonds | 60032301 | FDA UDI | Class I | Active |
| STATIM 5000 G4 Cassette Autoclave | G4-201103-L | FDA UDI | Class II | Active |
| DIATECH Diamonds | 60032016 | FDA UDI | Class I | Active |
| Alpen Diamonds | 60032621 | FDA UDI | Class I | Active |
| DIATECH Diamonds | 60032572 | FDA UDI | Class I | Active |
| Kenda | 0239.100 | FDA UDI | Class I | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Dent4you GmbH DE