SycoTec GmbH & Co. KG

SycoTec GmbH & Co. KG specializes in dental medical devices. Their portfolio includes high-speed dental handpieces like the SLM-E Typ 810 Ritter and A-dec XC10, dental cleaning systems such as the SciCan Dental Cleaner, dental lubricants like SciCan Dental Oil, motor spindles (e.g., Type KL7S), and STATMATIC NA, which appears to support dental radiography or imaging. These devices are designed for use in dental procedures and diagnostics.

SycoTec GmbH & Co. KG is based in Germany. The company’s headquarters and operations are located within the country, aligning with its focus on European medical device markets and regulatory compliance.

SycoTec GmbH & Co. KG’s devices are listed in the eudamed database, which is the official EU registry for medical devices. This registry ensures transparency and compliance with EU Medical Device Regulations (MDR) by documenting device information, manufacturers, and regulatory details.

SycoTec GmbH & Co. KG’s devices are classified under the EU Medical Device Regulations (MDR) as either Class I or Class IIa. Classification depends on factors like intended use, risk level, and interaction with the patient (e.g., handpieces and cleaning systems are typically lower-risk, while some imaging-related devices may fall into higher-risk categories). This classification determines the regulatory requirements for their design, manufacturing, and market placement.