Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rolence Ent., Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
86 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K093084 | ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP | Rolence Ent., Inc. | 2009-12-16 | 76 | 0 |
| K023545 | ULTRA-LITE 200E LIGHT CURE UNIT | Rolence Ent., Inc. | 2002-12-30 | 69 | 0 |
| K020884 | EXCELLITE LIGHT CURE UNIT | Rolence Ent., Inc. | 2002-06-12 | 86 | 0 |
| K020874 | ULTRA-LITE 5 TURBO LIGHT CURE UNIT | Rolence Ent., Inc. | 2002-06-12 | 86 | 0 |
| K020877 | EXCELLITE TURBO LIGHT CURE UNIT | Rolence Ent., Inc. | 2002-06-12 | 86 | 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