Data / Medical devices / Germany / Schlumbohm GMBH & Co. KG
Schlumbohm GMBH & Co. KG: FDA-registered device maker in Brokstedt Schleswig-Holstein, Germany, 1 510(k) clearance
Schlumbohm GMBH & Co. KG is registered with the FDA (registration 3018783058) in Brokstedt Schleswig-Holstein, Germany. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 13, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018783058
- Address
- Klein Floyen 8-10, Brokstedt Schleswig-Holstein, Germany, 24616
- Owner or operator
- Schlumbohm GmbH & Co. KG (10081593)
- Roles
- Manufacturer
- First device listed
- April 27, 2021
- Registered through
- 2026
- Brand names listed
- EndoPilot
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Handpiece, Direct Drive, Ac-Powered | EKX | 1 | Manufacturer | accessdata.fda.gov |
| Locator, Root Apex | LQY | U | Manufacturer | accessdata.fda.gov |
| Plugger, Root Canal, Endodontic | EKR | 1 | Manufacturer | accessdata.fda.gov |
| Scaler, Ultrasonic | ELC | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 13, 2021 | K202906 | EndoPilot2 | ELC | Substantially Equivalent | Schlumbohm GmbH & Co. KG | accessdata.fda.gov |
Compare with other makers
- All makers of Plugger, Root Canal, Endodontic
- All makers of Handpiece, Direct Drive, Ac-Powered
- All makers of Locator, Root Apex
- All makers of Scaler, Ultrasonic
Updated April 13, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.