Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dentalez, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
124 daysmedian FDA review time
146 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192412 | SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubri | Dentalez, Inc. | 2020-01-06 | 124 | 0 |
| K173465 | Concentrix MX-AC High-Speed Handpiece | Dentalez, Inc. | 2018-03-28 | 140 | 0 |
| K162397 | Titan 3 Low Speed Angle Attachments | Dentalez, Inc. | 2017-01-19 | 146 | 0 |
| K153411 | 430 Torque High-Speed Handpiece Series - 430 SWL Torque High | Dentalez, Inc. | 2016-04-08 | 135 | 0 |
| K113301 | CONCENPIECE,HIGH-SPEED HANDPIECE SERIES | Dentalez, Inc. | 2012-01-23 | 76 | 0 |
| K093072 | STARCARE HANDPIECE MAINTENANCE UNIT | Dentalez, Inc. | 2009-12-28 | 89 | 0 |
| K070869 | PROPHY STAR 3 HYGIENE HANDPIECE, MODEL 264422 | Dentalez, Inc. | 2007-06-15 | 78 | 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