Microp Technology (Taiwan), Inc.

Microp Technology (Taiwan), Inc. specialises in pneumatic dental power tool systems, specifically dental handpieces. These devices are designed for clinical use in dental procedures, providing controlled rotational power for tasks like drilling, cutting, or polishing teeth and restorative materials. The company’s focus is exclusively on dental tools within this category.

Microp Technology (Taiwan), Inc. is based in the United States, which means its devices are subject to FDA regulatory requirements. Since the company’s products are classified as Class I medical devices, they undergo authorisation through pathways like the 510(k) process and are tracked via the FDA’s UDI system. The US location ensures compliance with domestic regulatory standards.

Microp Technology (Taiwan), Inc.’s devices are authorised through the FDA’s 510(k) pathway and are included in the FDA’s UDI (Unique Device Identification) system. These registries ensure traceability and compliance tracking for Class I devices like their pneumatic dental handpieces, which are intended for controlled clinical use.

Microp Technology (Taiwan), Inc.’s pneumatic dental handpieces fall under the FDA’s Class I medical device classification. This classification is typically assigned to low-risk devices, such as dental tools with minimal risk to patients when used as intended. The classification determines the regulatory pathway—here, the 510(k) process—required to demonstrate safety and effectiveness before authorisation.