Manufacturer registered with FDA
Schlumbohm GmbH & Co. KG
Brokstedt, Germany. Lists 3 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 3
- Brands and models
- 3
- 510(k) clearances
- 12021–2021
- Markets registered in
- 644 registrations outside the US
- Establishments
- 1Germany
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name Schlumbohm GmbH & Co. KG as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Schlumbohm GmbH & Co. KG | 1 clearances | 2021–2021 | Below |
| Canada | Health Canada | Registration holder | SCHLUMBOHM GMBH & CO. KG | 32 | 2011–2016 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Schlumbohm GmbH & Co. KG | 6 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SCHLUMBOHM GMBH & CO. KG | 4 | 2012–2019 | Pure Global AI |
| Australia | TGA | Manufacturer | Schlumbohm GmbH & Co KG | 1 | 2018–2018 | Pure Global AI |
| China | NMPA | Registration holder | 德国实龙博姆有限公司Schlumbohm GmbH & Co. KG | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Schlumbohm GmbH & Co. KG currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | EndoPilot | 2021 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Maker | EndoPilot | 2021 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Maker | EndoPilot | 2021 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Schlumbohm GmbH & Co. KG as the applicant.
Some of these clearances are listed with FDA today by another company: Gebr. Brasseler GmbH & Co. KG (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SCHLUMBOHM GMBH & CO. KGFDA reg. 3018783058 | Brokstedt Schleswig-Holstein, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10081593). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.