Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mti Precision Products — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
50 daysmedian FDA review time
342 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K070001 | MASTER CLASSIC 5K LOW SPEED HANDPIECE, 20K LOW SPEED HANDPIE | Mti Precision Products | 2007-02-02 | 30 | 0 |
| K960541 | LYNX DPA DISPOSABLE PROPHY ANGLE | Mti Precision Products | 1996-03-28 | 50 | 0 |
| K940261 | LYNX LOW-SPEED HANDPIECE | Mti Precision Products | 1994-12-29 | 342 | 1 |
| K901488 | LYNX-SM, SCLAER DENTAL HANDPIECE | Mti Precision Products | 1990-05-15 | 47 | 0 |
| K895736 | LYNX-HIGH SPEED HANDPIECE | Mti Precision Products | 1989-12-18 | 83 | 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