QJC — Plaque Disclosing Agent Class I

FDA Device Classification

FDA product code QJC covers "Plaque Disclosing Agent", a Class I medical device regulated under 21 CFR 872.6855. Submissions are reviewed by the Dental panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
QJC
Device Class
Class I
Regulation Number
872.6855
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Definition

Intended to enhance visualization of the presence of plaque on tooth surfaces.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K770990evident dental co.DENTAL PLAQUE DISCLOSING AGENTJune 20, 1977