Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
3M Espe AG Dental Products · Predicate Candidate Screening
24 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
67 daysmedian FDA review time
101 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K100908 | UNICEM HM | 3M Espe AG Dental Products | 2010-06-22 | 82 | 0 |
| K100756 | MALTA | 3M Espe AG Dental Products | 2010-06-02 | 77 | 0 |
| K094007 | UNICEM | 3M Espe AG Dental Products | 2010-04-08 | 101 | 0 |
| K093721 | COSP2 | 3M Espe AG Dental Products | 2010-02-19 | 79 | 0 |
| K091826 | ELEGANT | 3M Espe AG Dental Products | 2009-09-25 | 98 | 0 |
| K090718 | BELLUS SHADING KIT | 3M Espe AG Dental Products | 2009-09-21 | 187 | 0 |
| K080514 | PECD-01 AND PECD QUICK-01 | 3M Espe AG Dental Products | 2008-03-26 | 30 | 0 |
| K072055 | LAVA FRAME, LAVA FRAME SHADE | 3M Espe AG Dental Products | 2008-02-26 | 215 | 0 |
| K073296 | TEMPXN28 | 3M Espe AG Dental Products | 2008-01-09 | 47 | 0 |
| K071131 | UNO | 3M Espe AG Dental Products | 2007-07-25 | 93 | 0 |
| K071260 | HERMES BOND 3 | 3M Espe AG Dental Products | 2007-07-17 | 71 | 0 |
| K062493 | LAVA SOFTWARE | 3M Espe AG Dental Products | 2006-11-17 | 84 | 0 |
| K060684 | ADPER PROMPT, ADPER PROMPT L-POP | 3M Espe AG Dental Products | 2006-04-24 | 40 | 0 |
| K053438 | GLASS CERAMICS | 3M Espe AG Dental Products | 2006-01-18 | 40 | 0 |
| K051797 | FUTURE WASH/YPS | 3M Espe AG Dental Products | 2005-07-21 | 16 | 0 |
| K043043 | HERMES BOND 2 | 3M Espe AG Dental Products | 2005-01-10 | 67 | 0 |
| K040857 | MODIFICATION TO ADPER PROMPT | 3M Espe AG Dental Products | 2004-05-10 | 38 | 0 |
| K033996 | HERMES | 3M Espe AG Dental Products | 2004-02-24 | 62 | 0 |
| K033974 | HERMES BOND | 3M Espe AG Dental Products | 2004-02-06 | 46 | 0 |
| K033022 | PROTEMP 3 GARANT | 3M Espe AG Dental Products | 2003-11-21 | 57 | 0 |
| K032001 | POLY Q (GARANT L, PENTA M, PENTA H) | 3M Espe AG Dental Products | 2003-08-11 | 45 | 0 |
| K021450 | CLINPRO PROPHY POWDER | 3M Espe AG Dental Products | 2002-08-01 | 87 | 0 |
| K020946 | ADPER PROMPT | 3M Espe AG Dental Products | 2002-04-04 | 10 | 0 |
| K020256 | UNICEM | 3M Espe AG Dental Products | 2002-03-25 | 60 | 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