Search Results

The Lakong 2200 Ultrasonic Scaler is intended for use during dental cleanings and periodontal therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.

Not Found

This document is a 510(k) clearance letter from the FDA for the Lakong 2200 Ultrasonic Scaler. It indicates that the device has been found substantially equivalent to a predicate device. However, this document does not contain the acceptance criteria, reported device performance, or details of a study proving the device meets acceptance criteria.

The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with specific performance acceptance criteria for devices like an ultrasonic scaler, which is in a lower risk class (Class II).

Therefore, I cannot provide the requested information from the given input. The document is too limited to answer the specific questions about acceptance criteria and detailed study information.

Ask a specific question about this device