Manufacturer registered with FDA
SycoTec GmbH & Co KG
Leutkirch, Germany. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 20
- 510(k) clearances
- 0as applicant
- Markets registered in
- 946 registrations outside the US
- Establishments
- 1Germany
Registered in 9 markets
Where regulators' registries name SycoTec 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 | SycoTec GmbH & Co KG | 3 device types | — | Below |
| Canada | Health Canada | Registration holder | SYCOTEC GMBH & CO. KG | 28 | 2007–2014 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | SycoTec GmbH & Co. KG | 8 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SYCOTEC GMBH &CO. KGSYCOTEC GMBH & CO. KG | 3 | 2011–2016 | Pure Global AI |
| Japan | PMDA | Registration holder | ＳｙｃｏＴｅｃ ＧｍｂＨ＆Ｃｏ． ＫＧ．ＳｙｃｏＴｅｃ ＧｍｂＨ＆Ｃｏ．ＫＧ | 2 | 2015–2020 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | SycoTec GmbH & Co. KG | 2 | — | Pure Global AI |
| Australia | TGA | Manufacturer | SycoTec GmbH & Co KG | 1 | 2026–2026 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | SycoTec GmbH & Co. KG | 1 | 2026–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | SycoTec GmbH & Co. KG | 1 | 2010–2010 | 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 SycoTec 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 |
|---|---|---|---|---|
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | Midwest Plus Automate SprayMidwest® 6-pin Coupler, K-style CESTATIS, ML and SLSTATMATIC 31 | 2014 |
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Maker | A-dec XC10 Electric MotorE-SANAO AdvantageE-SANAO PrepE-STATIS AdvantageE-STATIS PrepMidwest E Electric Handpiece SystemNUTORQUE PROGRAMMABLE ELECTRIC SYSTEMStar ETorque Electric Motor System | 2014 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Maker | ETorque HandpiecesMidwest E AttachmentsSANAO 10L/10SANAO 200LSANAO 40L/40SANAO 40STSANAO PSI/PSOSTERLING | 2014 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
SycoTec GmbH & Co KG lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Coltene/Whaledent AG (3).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 31 Jan 2014 | K132356 | SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST | Coltene/Whaledent AG | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 24 Jul 2009 | K090937 | E-STATIS 40 SYSTEM | Coltene/Whaledent AG | EBW Handpiece and Cord Foot Controller |
| 19 Oct 2006 | K062418 | K-SPRAY, MODEL 085-2715 | Coltene/Whaledent AG | EFB Dental Air-Powered Handpiece |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SYCOTEC GMBH & CO KGFDA reg. 3009302876 | Leutkirch Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10047093). 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.