Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mk-Dent GmbH · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K051872 | MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE | Mk-Dent GmbH | 2005-10-03 | 84 | 0 |
| K032234 | MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, | Mk-Dent GmbH | 2003-10-02 | 73 | 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