Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list LuxCreo with 5 510(k) clearances. The most recent is a 510(k) clearance dated Oct 23, 2026: LuxDesign.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 23, 2026 | LuxDesignK260421 · PNN | 510(k) clearances |
| Nov 25, 2025 | LuxCreo Flexible Partial Denture ResinK253365 · EBI | 510(k) clearances |
| Apr 8, 2025 | LuxCreo Clear Aligner SystemK250343 · NXC | 510(k) clearances |
| Jan 18, 2024 | LuxCreo Dental Night Guard ResinK230592 · MQC | 510(k) clearances |
| May 31, 2022 | LuxCreo Clear Aligner SystemK212680 · NXC | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
