DeviceClearance

Product code KKO— Dental

FLUID-FILLED TEETHER

Classification name
Ring, Teething, Fluid-Filled
Device class
Class 2
Regulation
21 CFR 872.5550
Advisory panel
Dental
Total cleared
27
First cleared
Most recent

Market context for product code KKO

FDA has cleared 27 devices under product code KKO between 1991 and 2013, filed by 24 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 KKO

Recent clearances under product code KKO

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