DeviceClearance

Product code QIA— Dental

Klinly Ultrasonic Tongue Cleaner

Classification name
Powered Tongue Scraper
Device class
Class 1
Regulation
21 CFR 872.6865
Advisory panel
Dental
Total cleared
1
First cleared
Most recent

FDA classification definition

“The device is intended to remove debris from the top surface of the tongue as a supplement to normal daily oral hygiene care.”

— U.S. Food and Drug Administration, device classification record for product code QIA under 21 CFR 872.6865, via openFDA

Market context for product code QIA

FDA has cleared 1 device under product code QIA, all in 2019, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code QIA

Recent clearances under product code QIA

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