Zoll-Dental

Zoll-Dental specializes in dental instruments, including reusable and single-use tools like tooth and root elevators for extractions, manual dental scalers for plaque removal, orthopaedic osteotomes for bone surgery, tooth extraction forceps, surgical scissors, retractors for gum exposure, and periosteal elevators. They also produce reusable amalgam carvers for precise dental restorations. These devices are designed for various dental and orthopaedic procedures.

Zoll-Dental is based in the United States, which means its devices are subject to FDA regulations. Since all listed devices fall under Class I classification, they are authorised through the FDA’s UDI (Unique Device Identification) system, ensuring compliance with US medical device requirements. The UDI system helps track and identify devices throughout their lifecycle.

Zoll-Dental’s devices are registered in the FDA’s UDI (Unique Device Identification) system, which is a centralised database for tracking and identifying medical devices in the US. This system ensures transparency and traceability for Class I devices, including those manufactured by Zoll-Dental.

All of Zoll-Dental’s listed devices are classified as Class I under US regulations. This classification applies to low-risk devices like dental instruments, which typically require less stringent premarket review. Authorisation is granted through the FDA’s UDI system, ensuring compliance without additional approval processes beyond registration.