TTBIO CORP.

TTBio Corp. specializes in dental power tool systems, focusing primarily on pneumatic and electric handpieces. These include high-speed and low-speed handpieces for dental procedures, as well as ultrasonic scalers and cleaning inserts. Examples of their products are the EVO 500K TL, EVO 700 series high-speed handpieces, and the EVOCLEAN Ultrasonic Scaler with its associated inserts. Their portfolio is designed to support various dental treatments.

TTBio Corp. is based in Taiwan. This means their devices must comply with both local Taiwanese regulations and international standards, such as those required for EU and US markets. Their products are listed in the EU’s eudamed database, the FDA’s 510(k) clearance system, and the FDA’s UDI registry, indicating they are designed to meet regulatory expectations in these regions.

TTBio Corp.’s devices are listed in the EU’s eudamed database, the FDA’s 510(k) clearance system, and the FDA’s Unique Device Identifier (UDI) registry. This is important because these registries provide transparency and traceability for healthcare professionals, regulators, and patients. Listing in these systems ensures compliance with EU MDR and US FDA requirements, facilitating market access and device tracking.

TTBio Corp.’s devices are classified under Class I, Class II, and Class IIa regulations. The classification depends on factors like the device’s risk level, intended use, and potential impact on patient safety. For example, high-speed handpieces like the EVO series may fall under Class II due to their procedural role in dental treatments, while simpler accessories like cleaning inserts might qualify as Class I. These classifications determine the regulatory scrutiny and compliance requirements each device must meet.