Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
3M Company, Unitek Orthodontic Products · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233257 | 3M™ Clarity™Aligners with Quick Attachments | 3M Company, Unitek Orthodontic Products | 2023-09-29 | 1 | 1 |
| K231464 | 3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clar | 3M Company, Unitek Orthodontic Products | 2023-05-22 | 3 | 0 |
| K211190 | 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity A | 3M Company, Unitek Orthodontic Products | 2021-04-23 | 2 | 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