DeviceClearance

Product code KIF— Dental

BIODENTINE

Classification name
Resin, Root Canal Filling
Device class
Class 2
Regulation
21 CFR 872.3820
Advisory panel
Dental
Total cleared
145
First cleared
Most recent

Market context for product code KIF

FDA has cleared 145 devices under product code KIF between 1977 and 2026, filed by 72 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 KIF

Recent clearances under product code KIF

1–100 of 145

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