LumiCare Caries Diagnostic Rinse
K-Number: K200601 · 2021-03-29
ApplicantGreenMark Biomedical, Inc.
Decision Date2021-03-29
Product CodeLFC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
LumiCare Caries Diagnostic Rinse is a medical device manufactured by GreenMark Biomedical, Inc.. It received FDA 510(k) clearance on 2021-03-29 under approval number K200601. The device is classified under product code LFC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the LumiCare Caries Diagnostic Rinse?
LumiCare Caries Diagnostic Rinse is a medical device that received FDA 510(k) clearance on 2021-03-29. It is manufactured by GreenMark Biomedical, Inc.. The 510(k) number is K200601.
When was LumiCare Caries Diagnostic Rinse approved by the FDA?
LumiCare Caries Diagnostic Rinse received FDA 510(k) clearance on 2021-03-29, under approval number K200601.
What company makes LumiCare Caries Diagnostic Rinse?
LumiCare Caries Diagnostic Rinse is manufactured by GreenMark Biomedical, Inc..
What is the FDA product code for LumiCare Caries Diagnostic Rinse?
The FDA product code for LumiCare Caries Diagnostic Rinse is LFC.
Other Devices by GreenMark Biomedical, Inc.
Related Devices (Code: LFC)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.