Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Espe GmbH & Co. Kg. — Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
71 daysmedian FDA review time
86 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K974231 | POSITION PENTA, POSITION PENTA QUICK | Espe GmbH & Co. Kg. | 1998-01-29 | 78 | 0 |
| K973513 | SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRAN | Espe GmbH & Co. Kg. | 1997-12-22 | 96 | 0 |
| K973262 | KETAC-FIL APLICAP PLUS | Espe GmbH & Co. Kg. | 1997-11-17 | 80 | 0 |
| K972892 | CAVIT-LC | Espe GmbH & Co. Kg. | 1997-10-02 | 58 | 0 |
| K963735 | COJET SYSTEM | Espe GmbH & Co. Kg. | 1996-11-27 | 71 | 0 |
| K963737 | HYCEM APLICAP | Espe GmbH & Co. Kg. | 1996-11-15 | 59 | 0 |
| K962428 | EBS (ESPE BONDING SYSTEM) | Espe GmbH & Co. Kg. | 1996-09-12 | 80 | 0 |
| K962442 | HYTAC APLITIP/HYTAC OSB | Espe GmbH & Co. Kg. | 1996-09-11 | 79 | 0 |
| K962440 | PERTAC II/PERTAC II APLITIP | Espe GmbH & Co. Kg. | 1996-09-11 | 79 | 0 |
| K960954 | KETAC-MOLAR APLICAP | Espe GmbH & Co. Kg. | 1996-05-16 | 66 | 0 |
| K960547 | DIMENSION PENTA/DIMENSION GARANT L/POLYVINYL SILOXANE ADHESI | Espe GmbH & Co. Kg. | 1996-03-15 | 36 | 0 |
| K954192 | IMPREGUM PENTA | Espe GmbH & Co. Kg. | 1995-12-01 | 86 | 0 |
| K954180 | MICROGLISS | Espe GmbH & Co. Kg. | 1995-11-21 | 76 | 0 |
| K953374 | PERMADYNE GARANT 2:1 | Espe GmbH & Co. Kg. | 1995-08-18 | 31 | 0 |
| K952693 | RAMITEC PENTA | Espe GmbH & Co. Kg. | 1995-08-18 | 66 | 0 |
| K953027 | PERMADYNE PENTA (HIGH & LOW VISCOSITY) | Espe GmbH & Co. Kg. | 1995-07-19 | 20 | 0 |
| K950203 | PROTEMP(R) GARANT | Espe GmbH & Co. Kg. | 1995-02-02 | 15 | 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