DeviceClearance

Product code LRK— Dental

ACRYLIC HERBST APPLIANCE

Classification name
Device, Anti-Snoring
Device class
Class 2
Regulation
21 CFR 872.5570
Advisory panel
Dental
Total cleared
215
First cleared
Most recent

Market context for product code LRK

FDA has cleared 215 devices under product code LRK between 1988 and 2026, filed by 155 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 LRK

Adverse events under product code LRK

product code LRK
Injury
246
Malfunction
1,044
Total
1,290

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 LRK

1–100 of 215

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