Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Midwest Orthodontic Mfg. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
75 daysmedian FDA review time
90 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K981433 | ORTHODONTIC BRACES | Midwest Orthodontic Mfg. | 1998-06-25 | 66 | 0 |
| K955740 | GLUFLORMA | Midwest Orthodontic Mfg. | 1996-02-08 | 55 | 0 |
| K952856 | LIGHT-CURE PC | Midwest Orthodontic Mfg. | 1995-09-12 | 82 | 0 |
| K952855 | PC-LOCK | Midwest Orthodontic Mfg. | 1995-09-08 | 78 | 0 |
| K952858 | LIGHT-CURE | Midwest Orthodontic Mfg. | 1995-09-05 | 75 | 0 |
| K952857 | PRO-LOCK | Midwest Orthodontic Mfg. | 1995-09-05 | 75 | 0 |
| K900824 | FLUOR-I-CHAINS(TM) AND FLUOR-I-TIES(TM) | Midwest Orthodontic Mfg. | 1990-05-22 | 90 | 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