Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ormco Corporation — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
233 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250487 | SparkTM Clear Aligner System | Ormco Corporation | 2025-02-20 | 1 | 0 |
| K250015 | Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Prim | Ormco Corporation | 2025-01-03 | 1 | 0 |
| K240501 | Spark™ Clear Aligner System | Ormco Corporation | 2024-10-11 | 233 | 0 |
| K203737 | Spark Clear Aligner System | Ormco Corporation | 2021-03-22 | 90 | 0 |
| K172845 | Symetri Clear | Ormco Corporation | 2018-01-31 | 134 | 0 |
| K171844 | Inspire ICE aka Inspire ICE Clear Brackets | Ormco Corporation | 2017-07-18 | 28 | 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