Product code KMW— Dental

E-TYPE SPEED REDUCER CONTRA ANGLE

Classification name
Handpiece, Rotary Bone Cutting
Device class
Class 2
Regulation
21 CFR 872.4120
Advisory panel
Dental
Total cleared
9
First cleared
Most recent

Market context for product code KMW

FDA has cleared 9 devices under product code KMW between 1986 and 2021, filed by 8 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

Top applicants under product code KMW

Adverse events under product code KMW

product code KMW
Injury
175
Total
175

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code KMW

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