Manufacturer registered with FDA
Microdental 2006 SL
Madrid, Spain. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Spain
Devices listed with FDA
What Microdental 2006 SL currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Sequential AlignerNXC · Class 2 | Clear aligners | Maker | Aligner SecuentialSMS aligner | 2023 |
| Indirect Bonding TrayQJJ · Class 1 | — | Maker | Ferula | 2023 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Microdental 2006 SL lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Xplora 3D Europe S.L (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 20 Dec 2024 | K242929 | Fas Aligner System | Xplora 3D Europe S.L | NXC Sequential Aligner |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Xplora 3D Europe SLFDA reg. 3022727952 | Madrid Madrid(Province), Spain | Contract manufacturer, Manufacturer |
Other names on FDA records
Xplora 3D Europe SL
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10087749). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.