FDA Product Code DZI: Drill, Bone, Powered
Leading manufacturers include Guangdong Jinme Medical Technology Co., Ltd., Mectron S.P.A. and Nakanishi, Inc..
FDA 510(k) Cleared Drill, Bone, Powered Devices (Product Code DZI)
About Product Code DZI - Regulatory Context
510(k) Submission Activity
48 total 510(k) submissions under product code DZI since 1979, with 48 receiving FDA clearance (average review time: 151 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under DZI have taken an average of 56 days to reach a decision - down from 157 days historically, suggesting improved FDA processing for this classification.
DZI devices are reviewed by the Dental panel. Browse all Dental devices →