Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Discus Dental, LLC — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
78 daysmedian FDA review time
126 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102639 | SL3 | Discus Dental, LLC | 2010-12-01 | 78 | 1 |
| K101612 | ZEN CORDLESS PROPHY SYSTEM | Discus Dental, LLC | 2010-06-30 | 21 | 0 |
| K101215 | NUANCE | Discus Dental, LLC | 2010-05-12 | 12 | 0 |
| K093208 | SIMPLISEAL | Discus Dental, LLC | 2010-02-12 | 122 | 0 |
| K092417 | INSIGHT ULTRASONIC INSERTS | Discus Dental, LLC | 2009-12-11 | 126 | 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