DeviceClearance

Product code DZI— Dental

AMORPHOUS DIAMOND COATED DRILL

Classification name
Drill, Bone, Powered
Device class
Class 2
Regulation
21 CFR 872.4120
Advisory panel
Dental
Total cleared
50
First cleared
Most recent

Market context for product code DZI

FDA has cleared 50 devices under product code DZI between 1979 and 2026, filed by 30 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code DZI

Recent clearances under product code DZI

Data sourced from openFDA. This site is unofficial and independent of the FDA.