Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
3M Unitek — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
71 daysmedian FDA review time
152 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K100536 | TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE | 3M Unitek | 2010-07-27 | 152 | 0 |
| K073697 | TRANSBOND SUPREME ADHESIVE | 3M Unitek | 2008-02-15 | 46 | 0 |
| K062305 | CLARITY MODIFIED CERAMIC BRACKETS | 3M Unitek | 2006-10-18 | 71 | 0 |
| K020394 | APC PLUS ADHESIVE | 3M Unitek | 2002-04-12 | 65 | 0 |
| K014142 | UNITE BONDING ADHESIVE | 3M Unitek | 2002-02-28 | 73 | 0 |
| K950514 | TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT | 3M Unitek | 1995-03-07 | 29 | 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