Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Midwest Dental Products Corp. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
288 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K973800 | 23:1 REDUCTION ANGLE | Midwest Dental Products Corp. | 1998-03-11 | 156 | 0 |
| K964755 | MICROJET CAVITY PREPARATION SYSTEM | Midwest Dental Products Corp. | 1997-09-11 | 288 | 0 |
| K962877 | MIDWEST 300 SE | Midwest Dental Products Corp. | 1996-10-18 | 86 | 0 |
| K963050 | TRADITION P, PUSH BUTTON HANDPIECE | Midwest Dental Products Corp. | 1996-10-11 | 66 | 3 |
| K955655 | MIDWEST ONE | Midwest Dental Products Corp. | 1996-03-05 | 84 | 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