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510(k) K200601

LumiCare Caries Diagnostic Rinse by GreenMark Biomedical, Inc. — Product Code LFC

K200601 is an FDA 510(k) premarket notification submitted by GreenMark Biomedical, Inc. for the device "LumiCare Caries Diagnostic Rinse". The FDA issued a decision of Substantially Equivalent on March 29, 2021. The device falls under product code LFC (Device, Caries Detection), a Class II device regulated under 21 CFR 872.1740. GreenMark Biomedical, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2021
Date Received
March 9, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Device, Caries Detection
Device Class
Class II
Regulation Number
872.1740
Review Panel
DE
Submission Type

Other clearances by GreenMark Biomedical, Inc.

  • K241568 — CrystLCare™ PRO Biorestorative, Fluoride-Plus (January 2, 2025)

Other clearances for product code LFC

  • K222560 — BlueCheck™ Caries Detection & Monitoring (May 16, 2023)
  • K193447 — Vista Dyes (March 11, 2020)
  • K102821 — DISCOVRED (March 11, 2011)
  • K060330 — SEE-IT CARIES DETECTOR (April 7, 2006)
  • K030807 — CARIES INDICATOR (June 9, 2003)
  • K012733 — CARIES DETECTOR (September 14, 2001)
  • K994368 — AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS (March 14, 2000)
  • K982105 — ORAL POTENTIAL METER (OPM) (September 16, 1998)
  • K973200 — CARIES STAIN (November 6, 1997)
  • K964430 — PULPDENT SNOOP (January 17, 1997)

FDA data resources