Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Steiner Laboratories — 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) |
|---|---|---|---|---|---|
| K142130 | ORAL BOND | Steiner Laboratories | 2016-06-06 | 672 | 0 |
| K113049 | SOCKET GRAFT | Steiner Laboratories | 2012-01-27 | 106 | 0 |
| K063010 | REGEN BIOCEMENT | Steiner Laboratories | 2006-11-28 | 57 | 0 |
| K052493 | SOCKET GRAFT | Steiner Laboratories | 2006-06-09 | 270 | 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