BioMTA

BioMTA specializes in dental devices primarily used in endodontic procedures. Their portfolio includes calcium silicate-based materials like RetroMTA, OrthoMTA, and SmartMTA, which are designed for filling and sealing root canals or orthodontic spaces. They also produce single-use dental syringe needles and ultrasonic handpiece tips (such as 0.3mm, 0.5mm, and CM tips) for scaling, debridement, and precision endodontic work. These products focus on biocompatibility and sealing integrity in dental treatments.

BioMTA is based in the United States, which means its devices are subject to FDA regulations. The company’s products fall under FDA’s Class I (generally low-risk) and Class II (moderate-risk) classifications, requiring submissions like 510(k) clearances and Unique Device Identifiers (UDIs) for tracking. Since the FDA oversees medical devices in the US, BioMTA’s devices are listed in the FDA’s regulatory databases (e.g., 510(k) and UDI registries) to demonstrate compliance with domestic standards.

BioMTA’s devices are documented in the FDA’s 510(k) clearance registry and the Unique Device Identifier (UDI) database. The 510(k) registry shows that individual devices have undergone premarket submissions to demonstrate safety and effectiveness compared to predicate devices, while the UDI system ensures traceability and transparency in the supply chain. These registries help healthcare providers, regulators, and distributors verify compliance and identify authorized products.

BioMTA’s devices are classified as either Class I or Class II under FDA regulations. Class I devices, like some single-use needles, generally pose minimal risk and may require only general controls (e.g., manufacturing practices). Class II devices, such as calcium silicate-based filling materials or ultrasonic tips, involve moderate risk and require additional controls like performance standards or post-market surveillance. The classification determines the regulatory pathway and ensures the device meets safety and effectiveness requirements for its intended use in dental procedures.