Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Svenska Dental Instruments AB — 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) |
|---|---|---|---|---|---|
| K022265 | LIGHT TIP | Svenska Dental Instruments AB | 2002-10-02 | 82 | 0 |
| K022264 | CLEAN 'N' OIL | Svenska Dental Instruments AB | 2002-10-02 | 82 | 0 |
| K892893 | SDI POLYCARBONATE CROWN, SCHEIN'S | Svenska Dental Instruments AB | 1989-06-06 | 47 | 0 |
| K892894 | S-FILE, S-FINDER, S-ENGINE FILE | Svenska Dental Instruments AB | 1989-05-24 | 34 | 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