510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K770990Substantially Equivalent

Dental Plaque Disclosing Agent

Evident Dental Co., Ltd., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K770990 is the FDA 510(k) clearance record for DENTAL PLAQUE DISCLOSING AGENT, a class I device, cleared for Evident Dental Co. , Ltd. on under FDA product code QJC (Plaque Disclosing Agent). FDA's definition for product code QJC reads: "Intended to enhance visualization of the presence of plaque on tooth surfaces". FDA records list one 510(k) clearance for Evident Dental Co. , Ltd. As of , FDA records show no recalls naming K770990.

Clearance record

Decision date
Received
(20 days to decision)
Product code
QJC Plaque Disclosing Agent
Regulation
21 CFR 872.6855
Device class
Class I
Review panel
Dental
Applicant
Evident Dental Co. , Ltd. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code QJC

Trailing 12 months

FDA records hold no clearances under product code QJC in the trailing twelve months.

FDA records show no clearances under product code QJC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QJC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260