Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Espe Dental AG · Predicate Candidate Screening
29 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
43 daysmedian FDA review time
84 days90th percentile
29clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K011394 | LAVA FRAME, LAVA FRAME SHADE, LAVA CERAM | Espe Dental AG | 2001-06-29 | 53 | 0 |
| K011154 | ELIPAR FREELIGHT | Espe Dental AG | 2001-05-16 | 30 | 0 |
| K002793 | KETAC CEM U | Espe Dental AG | 2000-09-26 | 19 | 0 |
| K002364 | PROTEMP H | Espe Dental AG | 2000-08-10 | 7 | 0 |
| K001494 | MODIFICATION TO PROMPT L-POP | Espe Dental AG | 2000-07-07 | 56 | 0 |
| K000595 | DIMENSION PENTA L | Espe Dental AG | 2000-04-05 | 43 | 0 |
| K000588 | DIMENSION GARANT L, DIMENSION GARANT L QUICK | Espe Dental AG | 2000-03-30 | 37 | 0 |
| K000591 | DIMENSION PENTA H, DIMENSION PENTA H QUICK | Espe Dental AG | 2000-03-30 | 37 | 1 |
| K994192 | IMPREGUM PENTA M MONOSOFT | Espe Dental AG | 2000-01-28 | 46 | 0 |
| K994193 | IMPREGUM PENTA DUOSOFT | Espe Dental AG | 2000-01-28 | 46 | 0 |
| K994190 | IMPREGUM GARANT L DUOSOFT | Espe Dental AG | 2000-01-27 | 45 | 0 |
| K994251 | KETAC-MOLAR QUICK | Espe Dental AG | 2000-01-03 | 17 | 0 |
| K993566 | PROMPTFLOW | Espe Dental AG | 1999-12-06 | 46 | 0 |
| K992909 | HYTAC | Espe Dental AG | 1999-11-24 | 86 | 0 |
| K992966 | REFERENCE | Espe Dental AG | 1999-10-07 | 35 | 0 |
| K992645 | SINFONY | Espe Dental AG | 1999-09-22 | 47 | 0 |
| K992897 | IMPREGUM PENTA | Espe Dental AG | 1999-09-08 | 12 | 0 |
| K992895 | IMPREGUM F | Espe Dental AG | 1999-09-08 | 12 | 0 |
| K992048 | MODIFICATION OF PROMPT L-POP | Espe Dental AG | 1999-08-16 | 60 | 1 |
| K991913 | PENTAMIX 2 | Espe Dental AG | 1999-07-26 | 49 | 0 |
| K991008 | DIMENSION BITE | Espe Dental AG | 1999-06-18 | 84 | 0 |
| K990763 | VITRON M | Espe Dental AG | 1999-05-25 | 78 | 0 |
| K991221 | VESTOGUM | Espe Dental AG | 1999-05-20 | 38 | 0 |
| K991220 | VITRON H | Espe Dental AG | 1999-05-20 | 38 | 0 |
| K990982 | CAVIT LC | Espe Dental AG | 1999-04-23 | 30 | 0 |
| K984247 | ELIPAR TRILIGHT | Espe Dental AG | 1999-02-25 | 90 | 0 |
| K984248 | PROCEM | Espe Dental AG | 1999-01-08 | 42 | 0 |
| K984246 | PROMPT L-POP | Espe Dental AG | 1999-01-08 | 42 | 0 |
| K983414 | EVERBOND | Espe Dental AG | 1998-12-16 | 79 | 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