Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dent4you AG — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250969 | JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST | Dent4you AG | 2025-06-27 | 88 | 0 |
| K242360 | Speedex Light Body; Speedex Medium; Speedex Putty; Speedex P | Dent4you AG | 2024-11-15 | 98 | 0 |
| K240801 | BioSonic US200 Ultrasonic Scaler (60034537) | Dent4you AG | 2024-07-01 | 98 | 0 |
| K223142 | Coltolux Comfort LED Curing Light | Dent4you AG | 2022-12-22 | 79 | 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