DeviceClearance

Product code KLE— Dental

CLEARFIL LINER BOND 2

Classification name
Agent, Tooth Bonding, Resin
Device class
Class 2
Regulation
21 CFR 872.3200
Advisory panel
Dental
Total cleared
419
First cleared
Most recent

Market context for product code KLE

FDA has cleared 419 devices under product code KLE between 1976 and 2026, filed by 136 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 KLE

Recent clearances under product code KLE

1–100 of 419

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