Dent4You AG
Active in EUDAMEDSwitzerlandfrom SRN EUDAMED FDA SRN CH-MF-000028926 FEI 3022516928
Dent4You AG is a medical device manufacturer based in Switzerland, with 3,000 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class I and II; EU Class IIa and I) as of 12 Nov 2026.
- Devices
- 3,000
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 2,818
- EUDAMED 1,680
- FDA 510(k) 4
- Device classes
- FDA Class I 1,863
- EU Class IIa 813
- FDA Class II 163
- EU Class I 161
- Top EMDN categories
- Sites and related companies
- Coltène/Whaledent GmbH + Co. KG authorised representative
- Dent4you GmbH authorised representative
- Identifiers
- EUDAMED SRN CH-MF-000028926
- FDA FEI 3022516928
- DUNS 480152811
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment
- Authorised rep.
- Coltène/Whaledent GmbH + Co. KGDE
- Authorised rep.
- Dent4you GmbHDE
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.
Catalogue
Search and filter all 3,000 devicesShowing 1-50 of 3,000
Company details
- EUDAMED SRN
- CH-MF-000028926
- FDA FEI number
- 3022516928
- DUNS number
- 480152811
- EUDAMED status
- Active
- EUDAMED registered name
- Dent4You AG
- Registered address
- 2, Bahnhofstr., 9435, Heerbrugg, Switzerland
- info.ch@coltene.com
- Phone
- +41717575300
- PRRC contact
- Kelly Makimoto
FDA establishments
- Dent4you GmbH DE
Frequently asked questions
How many devices does Dent4You AG have in the registry?
The registry currently lists 3000 devices for Dent4You AG. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dent4You AG's devices?
Among its 50 most recently registered devices, Dent4You AG has devices listed in EUDAMED (7 devices) and FDA GUDID (44 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Dent4You AG's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Dent4You AG's devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dent4You AG in the registry?
The most recently registered devices listed for Dent4You AG include BRILLIANT EverGlow Starter Kit, Syringes, 7 x 3 g, OPTIM 1 Wipes, ORBIS Dental Polisher medium yellow minipoint for composite and ORBIS Dental Polisher fine blue minipoint for composite.
Which FDA establishments are linked to Dent4You AG?
1 FDA establishment is linked to Dent4You AG in the registry; they are listed on the company page.