Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nobio , Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
288 daysmedian FDA review time
329 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K201010 | Infinix Universal Composite, Infinix Flowable Composite, Inf | Nobio , Ltd. | 2020-08-14 | 119 | 0 |
| K183391 | Novidia Universal Bond | Nobio , Ltd. | 2019-09-24 | 291 | 0 |
| K182921 | Infinix Universal Composite | Nobio , Ltd. | 2019-09-13 | 329 | 0 |
| K182714 | Novidia Bulk Fill Flow Composite | Nobio , Ltd. | 2019-07-12 | 288 | 0 |
| K182580 | Novidia Flowable Composite | Nobio , Ltd. | 2019-07-03 | 287 | 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