Product code QJC— Dental

DENTAL PLAQUE DISCLOSING AGENT

Classification name: Plaque Disclosing Agent
Device class: Class 1
Regulation: 21 CFR 872.6855
Advisory panel: Dental
Total cleared: 1
First cleared: 1977-06-20
Most recent: 1977-06-20

FDA classification definition

“Intended to enhance visualization of the presence of plaque on tooth surfaces.”
— U.S. Food and Drug Administration, device classification record for product code QJC under 21 CFR 872.6855, via openFDA

Market context for product code QJC

FDA has cleared 1 device under product code QJC, all in 1977, 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 QJC

Evident Dental Co. , Ltd.1 clearance

Recent clearances under product code QJC

K770990 — DENTAL PLAQUE DISCLOSING AGENTEvident Dental Co. , Ltd.·1977-06-20

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