LumiCare Caries Diagnostic Rinse— 510(k) K200601

Name: FDA 510(k) clearance K200601
Creator: U.S. Food and Drug Administration
Published: 2021-03-29

Substantially Equivalent

GreenMark Biomedical, Inc.

FDA 510(k) clearance K200601 for LumiCare Caries Diagnostic Rinse, Substantially Equivalent on 2021-03-29. Applicant: GreenMark Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: GreenMark Biomedical, Inc.
Product code: Code LFC
Device class: Class 2
Regulation: 21 CFR 872.1740
Advisory panel: Dental
Date received: 2020-03-09
Decision date: 2021-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Lansing, MI, US

Download summary PDF View on FDA.gov ↗

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