Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Handpiece Headquarters — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
104 daysmedian FDA review time
177 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243911 | HPR Cordless Hygiene Handpiece | Handpiece Headquarters | 2024-12-20 | 1 | 0 |
| K233518 | BASE290 LED Curing Light | Handpiece Headquarters | 2023-11-02 | 1 | 0 |
| K143183 | Maxima XTEND Handpiece Maintenance System | Handpiece Headquarters | 2015-02-17 | 104 | 0 |
| K141125 | U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE | Handpiece Headquarters | 2014-10-23 | 175 | 0 |
| K100389 | HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HA | Handpiece Headquarters | 2010-08-12 | 177 | 0 |
| K092053 | MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH | Handpiece Headquarters | 2009-08-20 | 44 | 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