Data / Medical devices / Germany / Medealis GMBH
Medealis GMBH: FDA-registered device maker in Abtsteinach Hesse, Germany, 8 510(k) clearances
Medealis GMBH is registered with the FDA (registration 3017064961) in Abtsteinach Hesse, Germany. It lists 3 device types. The FDA files 8 510(k) clearances under its listings, the newest dated April 16, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3017064961
- Address
- Im Steinboehl 9, Abtsteinach Hesse, Germany, 69518
- Owner or operator
- MEDEALIS GmbH (10094093)
- Roles
- Exporter to the US
- First device listed
- November 20, 2025
- Registered through
- 2027
- Brand names listed
- DESS Dental Smart Solutions
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Exporter to the US | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Exporter to the US | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 16, 2026 | K253804 | DESS Dental Smart Solutions | NHA | Substantially Equivalent | Terrats Medical SL | accessdata.fda.gov |
| October 31, 2025 | K251547 | DESS Dental Smart Solutions | NHA | Substantially Equivalent | Terrats Medical SL | accessdata.fda.gov |
| July 23, 2025 | K251280 | DESS® Dental Implants | DZE | Substantially Equivalent | Terrats Medical SL | accessdata.fda.gov |
| November 5, 2024 | K242340 | DESS Dental Smart Solutions | NHA | Substantially Equivalent | Terrats Medical SL | accessdata.fda.gov |
| October 27, 2022 | K222288 | DESS Dental Smart Solutions | NHA | Substantially Equivalent | Terrats Medical SL | accessdata.fda.gov |
| March 11, 2022 | K212628 | DESS Dental Smart Solutions | NHA | Substantially Equivalent | Terrats Medical SL | accessdata.fda.gov |
| November 10, 2019 | K191986 | DESS Dental Smart Solutions | NHA | Substantially Equivalent | Terrats Medical SL | accessdata.fda.gov |
| August 8, 2017 | K170588 | DESS Dental Smart Solutions | NHA | Substantially Equivalent | Terrats Medical SL | accessdata.fda.gov |
Compare with other makers
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
- All makers of Accessories, Implant, Dental, Endosseous
Updated April 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.