Berman Instruments LLC

Berman Instruments LLC specializes in reusable dental instruments, primarily periodontal probes and endodontic explorers. Their product line includes standard periodontal probes like the #5 Explorer and Nabers Probe 2N, as well as specialized tools such as the DG16 Double End Explorer. These devices are designed for dental examinations and root canal procedures, focusing on precision and ergonomic usability.

Berman Instruments LLC is based in the United States, meaning their devices are manufactured and distributed under U.S. regulatory oversight. This includes compliance with applicable U.S. medical device standards, though individual devices must still undergo their own regulatory pathways (e.g., FDA clearance or exemption) to be legally marketed.

Yes, Berman Instruments LLC’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices by assigning standardized identifiers, ensuring traceability and transparency in the supply chain. Listing in the UDI database is a requirement for Class I devices in the U.S.

Berman Instruments LLC’s devices are classified as Class I under FDA regulations. This classification applies to low-risk devices like periodontal probes and endodontic explorers, which generally require less stringent premarket review. However, even Class I devices must still comply with FDA requirements, such as registration, listing, and UDI labeling, to ensure safety and effectiveness.