Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
W&H Dentalwerk Bürmoos GmbH · 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) |
|---|---|---|---|---|---|
| K253655 | Angled Screwdriver MED (M-SD090) | W&H Dentalwerk Bürmoos GmbH | 2026-07-31 | 253 | 0 |
| K242179 | Synea Fusion Handpieces (Intensiv & Profin) | W&H Dentalwerk Bürmoos GmbH | 2025-02-28 | 218 | 0 |
| K162926 | Air-Powered Handpieces and Handpiece Attachments | W&H Dentalwerk Burmoos GmbH | 2017-02-23 | 127 | 0 |
| K161957 | W&H Implantmed SI-1015 incl. Accessories | W&H Dentalwerk Burmoos GmbH | 2016-11-23 | 128 | 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