Data / Medical devices / United States / Luxcreo Inc.
Luxcreo Inc.: FDA-registered device maker in Chicago, IL, United States, 4 510(k) clearances
Luxcreo Inc. is registered with the FDA (registration 3016237718) in Chicago, IL, United States. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated November 25, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016237718
- Address
- 350 W. Ontario Street Suite 700 Chicago,lL.60654, Chicago, IL, United States, 60654
- Owner or operator
- LuxCreo Inc. (10071055)
- Roles
- Manufacturer, Specification developer
- First device listed
- April 20, 2020
- Registered through
- 2026
- Brand names listed
- FPD Reisn, LuxCreo Clear Aligner System, LuxCreo Clear Retainer System, LuxCreo Dental Clear Aligner Resin, LuxCreo Dental Night Guard Resin
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aligner, Sequential | NXC | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Maintainer, Space Preformed, Orthodontic | DYT | 1 | Specification developer | accessdata.fda.gov |
| Mouthguard, Prescription | MQC | U | Specification developer | accessdata.fda.gov |
| Plate, Base, Shellac | EEA | 1 | Specification developer | accessdata.fda.gov |
| Positioner, Tooth, Preformed | KMY | 1 | Specification developer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| November 25, 2025 | K253365 | LuxCreo Flexible Partial Denture Resin | EBI | Substantially Equivalent | LuxCreo, Inc. | accessdata.fda.gov |
| April 8, 2025 | K250343 | LuxCreo Clear Aligner System | NXC | Substantially Equivalent | LuxCreo, Inc. | accessdata.fda.gov |
| January 18, 2024 | K230592 | LuxCreo Dental Night Guard Resin | MQC | Substantially Equivalent | LuxCreo, Inc. | accessdata.fda.gov |
| May 31, 2022 | K212680 | LuxCreo Clear Aligner System | NXC | Substantially Equivalent | LuxCreo, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Aligner, Sequential
- All makers of Positioner, Tooth, Preformed
- All makers of Mouthguard, Prescription
- All makers of Maintainer, Space Preformed, Orthodontic
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Plate, Base, Shellac
Updated November 25, 2025. 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.