DeviceClearance

Product code LBH— Dental

CAVITY VARNISH

Classification name
Varnish, Cavity
Device class
Class 2
Regulation
21 CFR 872.3260
Advisory panel
Dental
Total cleared
139
First cleared
Most recent

Market context for product code LBH

FDA has cleared 139 devices under product code LBH between 1976 and 2026, filed by 80 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 LBH

Recent clearances under product code LBH

1–100 of 139

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