Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Discus Dental, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
197 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K073518 | FLASHLITE REBEL* | Discus Dental, Inc. | 2007-12-20 | 6 | 0 |
| K062176 | RELIEF ACP ORAL CARE GEL | Discus Dental, Inc. | 2007-01-10 | 163 | 1 |
| K052090 | SPLASH! IMPRESSION MATERIAL DEVICE | Discus Dental, Inc. | 2005-08-05 | 3 | 0 |
| K051776 | PROTEGE ULTRASONIC INSERT | Discus Dental, Inc. | 2005-07-13 | 12 | 0 |
| K033785 | PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE | Discus Dental, Inc. | 2004-06-18 | 197 | 0 |
| K040053 | PRECISION VPS IMPRESSION MATERIAL | Discus Dental, Inc. | 2004-03-25 | 73 | 0 |
| K033381 | DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE W | Discus Dental, Inc. | 2004-01-27 | 97 | 0 |
| K030776 | MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL | Discus Dental, Inc. | 2003-05-09 | 59 | 0 |
| K023748 | FLASH-LITE II LED DENTAL CURING LIGHT | Discus Dental, Inc. | 2003-01-17 | 70 | 0 |
| K022184 | FLASH-LITE LED DENTAL CURING LIGHT | Discus Dental, Inc. | 2002-08-20 | 48 | 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