Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Premium Plus (Dongguan) Limited · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251869 | Disposable Prophy Angle (3399-60, 3399-090, 3399-105) | Premium Plus (Dongguan) Limited | 2025-09-15 | 89 | 0 |
| K250009 | LED Curing Light (C01-X, C02-X) | Premium Plus (Dongguan) Limited | 2025-04-10 | 98 | 0 |
| K220662 | Disposable Barrier Sleeves | Premium Plus (Dongguan) Limited | 2022-05-11 | 65 | 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