Cleared Traditional

LumiCare Caries Diagnostic Rinse

K200601 · GreenMark Biomedical, Inc. · Dental
Mar 2021
Decision
385d
Days
Class 2
Risk

About This 510(k) Submission

K200601 is an FDA 510(k) clearance for the LumiCare Caries Diagnostic Rinse, a Device, Caries Detection (Class II — Special Controls, product code LFC), submitted by GreenMark Biomedical, Inc. (East Lansing, US). The FDA issued a Cleared decision on March 29, 2021, 385 days after receiving the submission on March 9, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.1740.

Submission Details

510(k) Number K200601 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 2020
Decision Date March 29, 2021
Days to Decision 385 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LFC — Device, Caries Detection
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1740