Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KMW — Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
87 daysmedian FDA review time
340 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K211584 | Oral Surgery Contra | Nakanishi, Inc. | 2021-08-19 | 87 | 0 |
| K171155 | Surgical Angle Handpiece, Surgical Straight Handpiece | Nakanishi, Inc. | 2017-11-21 | 215 | 8 |
| K162544 | OsteoMed PINNACLE Driver | Osteomed | 2017-04-04 | 204 | 0 |
| K080939 | SURGICAL HANDPIECES, MIKRO SAW HANDPIECES | W&H Dentalwerk Buermoos GmbH | 2008-07-29 | 117 | 1 |
| K994298 | FRIOS MICROSAW | Friadent GmbH | 2000-02-18 | 59 | 0 |
| K971692 | OSTEOPOWER SYSTEM AND ACCESSORIES | Osteomed Corp. | 1997-06-27 | 51 | 0 |
| K970953 | E-TYPE SPEED REDUCER CONTRA ANGLE | Nsk Nakanishi, Inc. | 1997-04-15 | 29 | 0 |
| K932255 | YOUNG D'GRANULATOR | Young Dental Manufacturing Co. 1, LLC | 1994-04-15 | 340 | 0 |
| K862110 | OSSEODENT DRILLING SYSTEM | Otc/America | 1986-08-07 | 65 | 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