Data / Medical devices / Spain / Xplora 3D Europe SL
Xplora 3D Europe SL: FDA-registered device maker in Madrid Madrid(Province), Spain, 1 510(k) clearance
Xplora 3D Europe SL is registered with the FDA (registration 3022727952) in Madrid Madrid(Province), Spain. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 20, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3022727952
- Address
- Calle Juan De La Cierva 70. 28939 Arroyomolinos, Madrid Madrid(Province), Spain, 28939
- Owner or operator
- Microdental 2006 SL (10087749)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- April 4, 2023
- Registered through
- 2026
- Brand names listed
- Aligner Secuential, Ferula, SMS aligner
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aligner, Sequential | NXC | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Indirect Bonding Tray | QJJ | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| December 20, 2024 | K242929 | Fas Aligner System | NXC | Substantially Equivalent | Xplora 3D Europe S.L | accessdata.fda.gov |
Compare with other makers
Updated December 20, 2024. 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.