Background: This study aimed to evaluate the effect of a prefabricated functional appliance (Myobrace®) on skeletal, dental, and soft tissue components in children with Class II, division 1 malocclusion. Methods: Thirteen patients with Class II, division 1 malocclusion (9 girls and 4 boys; mean age, 8.2±0.9 years at the start and 9.3±1.0 years at the end of the treatment) were treated with Myobrace® for a mean period of 12.9±4.0 months. Patients were instructed to use the appliance daily for 1 hour and overnight while sleeping. A control group of 10 patients with untreated Class II, division 1 malocclusion (3 girls and 7 boys; mean age, 9.0±1.6 years at the start and 10.4±2.1 years at the end of the observation) was included to eliminate possible growth effects. The mean observation period for this group was 17.7±11.2 months. Lateral cephalograms were taken at the start and end of the treatment, and findings from 41 measurements were analyzed using the V-CephTM program. The mean and standard deviation of cephalometric measurements were analyzed using paired and independent sample t-tests. Results: The treatment group showed significant changes in SNB, ANB, maxillary protrusion, ramus height, proclination of upper anterior teeth, interincisal angle, overjet, and upper lip protrusion compared with the control group. However, only decrease in ANB, maxillary protrusion, overjet, upper lip protrusion, and increase in interincisal angle were significantly higher in the treatment group than in the control group. Conclusion: The prefabricated functional appliance induced skeletal, dentoalveolar, and soft tissue changes, resulting in a significant reduction in anteroposterior discrepancy.