Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Panthera Dental, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
181 daysmedian FDA review time
268 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203596 | Panthera Occlusal Appliance | Panthera Dental, Inc. | 2021-04-20 | 132 | 0 |
| K192108 | Panthera Dental Milled Bars | Panthera Dental, Inc. | 2020-04-08 | 247 | 0 |
| K183580 | Panthera Dental Milled Bars | Panthera Dental, Inc. | 2019-06-20 | 181 | 0 |
| K171576 | The Panthera Anti-Snoring X3 Device | Panthera Dental, Inc. | 2018-02-22 | 268 | 0 |
| K173466 | Panthera Dental Milled Bars | Panthera Dental, Inc. | 2018-01-26 | 79 | 0 |
| K143244 | The Panthera Anti-Snoring Device | Panthera Dental, Inc. | 2014-12-15 | 33 | 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