Luxcreo Inc.
Chicago, IL, US
LUXCREO INC. appears in FDA device records in Chicago, IL. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Luxcreo Inc. between 2022 and 2025. The busiest year on record is 2025, with 2. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2022 | 1 |
| 2024 | 1 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253365 | LuxCreo Flexible Partial Denture Resin | EBI | Substantially Equivalent | |
| K250343 | LuxCreo Clear Aligner System | NXC | Substantially Equivalent | |
| K230592 | LuxCreo Dental Night Guard Resin | MQC | Substantially Equivalent | |
| K212680 | LuxCreo Clear Aligner System | NXC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3016237718 | 3016237718 | LUXCREO INC. | 350 W. Ontario Street Suite 700 Chicago,lL.60654, Chicago, IL 60654 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain