Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Espe GmbH (Us) · Predicate Candidate Screening
59 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
206 days90th percentile
59clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K925027 | PHOTAC-FIL APLICAP | Espe GmbH (Us) | 1993-06-18 | 259 | 0 |
| K915005 | PHOTAC-BOND APLICAP, MODIFICATION | Espe GmbH (Us) | 1992-01-14 | 68 | 0 |
| K913966 | SONO(R) -CEM | Espe GmbH (Us) | 1992-01-14 | 131 | 0 |
| K913857 | ROCATEC(R) -PLUS | Espe GmbH (Us) | 1991-12-16 | 111 | 0 |
| K913965 | ESPE(R) -SIL | Espe GmbH (Us) | 1991-12-04 | 90 | 0 |
| K905604 | VISIO-GEM ART-SYSTEM | Espe GmbH (Us) | 1991-03-29 | 108 | 0 |
| K904096 | PHOTAC-BOND | Espe GmbH (Us) | 1990-11-19 | 74 | 0 |
| K904097 | PHOTAC-BOND APLICAP | Espe GmbH (Us) | 1990-11-09 | 64 | 0 |
| K904289 | PERTAC UNIVERSAL BOND | Espe GmbH (Us) | 1990-11-01 | 45 | 0 |
| K900510 | PERTAC-HYBRID | Espe GmbH (Us) | 1990-08-09 | 188 | 0 |
| K900558 | PERTAC BOND | Espe GmbH (Us) | 1990-04-10 | 62 | 0 |
| K900436 | PROTEMP II | Espe GmbH (Us) | 1990-03-28 | 57 | 0 |
| K897188 | KETAC-CEM MAXICAP | Espe GmbH (Us) | 1990-03-27 | 89 | 0 |
| K896539 | PERMADYNE GARANT LOW VISCOSITY | Espe GmbH (Us) | 1990-02-09 | 86 | 0 |
| K892412 | POLYETHER-RETARDER | Espe GmbH (Us) | 1989-12-04 | 238 | 0 |
| K892839 | PALGARAPID | Espe GmbH (Us) | 1989-10-27 | 192 | 0 |
| K892517 | TULUX-FILTER | Espe GmbH (Us) | 1989-08-21 | 132 | 0 |
| K891064 | ESPE CAPMIX | Espe GmbH (Us) | 1989-05-30 | 90 | 0 |
| K891020 | ESPE TULUX-CEM | Espe GmbH (Us) | 1989-05-26 | 87 | 0 |
| K884752 | KETAC-GLAZE | Espe GmbH (Us) | 1989-01-19 | 66 | 0 |
| K884381 | PALGAFLEX AND PALGAFLEX-QUICK | Espe GmbH (Us) | 1989-01-04 | 78 | 0 |
| K884475 | CHELON-FIL | Espe GmbH (Us) | 1988-12-05 | 41 | 0 |
| K882566 | VISIO-PERL | Espe GmbH (Us) | 1988-10-19 | 119 | 0 |
| K881838 | MODIFIED PERMAGUM ADHESIVE | Espe GmbH (Us) | 1988-07-27 | 86 | 0 |
| K880741 | ESPE VARNISH | Espe GmbH (Us) | 1988-07-01 | 128 | 0 |
| K874788 | KETAC-BOND APLICAP | Espe GmbH (Us) | 1988-04-12 | 141 | 0 |
| K872984 | KETAC-CONDITIONER | Espe GmbH (Us) | 1988-03-09 | 222 | 0 |
| K875257 | IMPREGUM F ADHESIVE | Espe GmbH (Us) | 1988-03-09 | 78 | 0 |
| K875228 | PERMADYNE ADHESIVE | Espe GmbH (Us) | 1988-03-09 | 78 | 0 |
| K875133 | CAVIT-W | Espe GmbH (Us) | 1988-03-01 | 77 | 0 |
| K873882 | ALKALINER | Espe GmbH (Us) | 1988-02-26 | 156 | 0 |
| K873069 | MODIFIED VISIO-SEAL | Espe GmbH (Us) | 1987-09-15 | 40 | 0 |
| K865028 | ESPE CHELON-SILVER | Espe GmbH (Us) | 1987-02-19 | 58 | 0 |
| K862292 | ESPE VISIO-MOLAR | Espe GmbH (Us) | 1986-08-18 | 62 | 0 |
| K853529 | IMPREGUM-F | Espe GmbH (Us) | 1986-03-17 | 206 | 0 |
| K844844 | ESPE NIMETIC-GRIP | Espe GmbH (Us) | 1986-02-13 | 427 | 0 |
| K844845 | ESPE KETAC-BOND | Espe GmbH (Us) | 1985-08-19 | 249 | 0 |
| K844846 | ESPE KETAC-CEM RADIOPAQUE | Espe GmbH (Us) | 1985-03-25 | 102 | 0 |
| K843566 | KETAC-SILVER | Espe GmbH (Us) | 1984-12-06 | 87 | 0 |
| K833757 | VISIO-GEM | Espe GmbH (Us) | 1984-02-03 | 100 | 0 |
| K822452 | PROTEMP | Espe GmbH (Us) | 1982-09-28 | 43 | 0 |
| K822453 | VISIO-OPAQUER | Espe GmbH (Us) | 1982-09-14 | 29 | 0 |
| K812169 | VISIO-FIL | Espe GmbH (Us) | 1981-09-08 | 40 | 0 |
| K790823 | VISIO-DISPERS | Espe GmbH (Us) | 1979-10-22 | 174 | 0 |
| K790832 | KETAC APPLIC-CAPSULES | Espe GmbH (Us) | 1979-04-30 | 0 | 0 |
| K790833 | VISIO-BOND | Espe GmbH (Us) | 1979-04-30 | 0 | 0 |
| K771852 | NIMETIC POLISHING PASTE | Espe GmbH (Us) | 1977-11-02 | 34 | 0 |
| K771853 | PERMAGUM ADHESIVE | Espe GmbH (Us) | 1977-10-13 | 14 | 0 |
| K771654 | NIMETICAP | Espe GmbH (Us) | 1977-09-06 | 8 | 0 |
| K771627 | PERMAGUM | Espe GmbH (Us) | 1977-09-02 | 7 | 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