Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JEP · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K091533 | SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM15 | Garrison Dental Solutions | 2009-08-17 | 83 | 0 |
| K930151 | OMNI-MATRIX | Innovative Technology , Ltd. | 1993-09-23 | 254 | 0 |
| K831136 | DOUBLE BOW TOOTH SEPARATOR | Almore Intl., Inc. | 1983-06-08 | 62 | 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