Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LuxCreo, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253365 | LuxCreo Flexible Partial Denture Resin | LuxCreo, Inc. | 2025-11-25 | 56 | 0 |
| K250343 | LuxCreo Clear Aligner System | LuxCreo, Inc. | 2025-04-08 | 61 | 0 |
| K230592 | LuxCreo Dental Night Guard Resin | LuxCreo, Inc. | 2024-01-18 | 321 | 0 |
| K212680 | LuxCreo Clear Aligner System | LuxCreo, Inc. | 2022-05-31 | 280 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda