Espe GmbH & Co. KG.
Seefeld, DE
Espe GmbH & Co. Kg. appears in FDA device records in Seefeld, DE. FDA records list 17 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 17
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 17 510(k) clearances for Espe GmbH & Co. KG. between 1995 and 1998. The busiest year on record is 1996, with 7. The most recent is 1998, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 6 |
| 1996 | 7 |
| 1997 | 3 |
| 1998 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K974231 | POSITION PENTA, POSITION PENTA QUICK | ELW | Substantially Equivalent | |
| K973513 | SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL,SINFONY MAGIC MODIFIERS, SINFONY OPAQUER | EBF | Substantially Equivalent | |
| K973262 | KETAC-FIL APLICAP PLUS | EMA | Substantially Equivalent | |
| K972892 | CAVIT-LC | EBF | Substantially Equivalent | |
| K963735 | COJET SYSTEM | EBF | Substantially Equivalent | |
| K963737 | HYCEM APLICAP | EMA | Substantially Equivalent | |
| K962428 | EBS (ESPE BONDING SYSTEM) | KLE | Substantially Equivalent | |
| K962442 | HYTAC APLITIP/HYTAC OSB | EBF | Substantially Equivalent | |
| K962440 | PERTAC II/PERTAC II APLITIP | EBF | Substantially Equivalent | |
| K960954 | KETAC-MOLAR APLICAP | EMA | Substantially Equivalent | |
| K960547 | DIMENSION PENTA/DIMENSION GARANT L/POLYVINYL SILOXANE ADHESIVE | ELW | Substantially Equivalent | |
| K954192 | IMPREGUM PENTA | ELW | Substantially Equivalent | |
| K954180 | MICROGLISS | ELW | Substantially Equivalent | |
| K953374 | PERMADYNE GARANT 2:1 | ELW | Substantially Equivalent | |
| K952693 | RAMITEC PENTA | ELW | Substantially Equivalent | |
| K953027 | PERMADYNE PENTA (HIGH & LOW VISCOSITY) | ELW | Substantially Equivalent | |
| K950203 | PROTEMP(R) GARANT | EBG | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain