Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- EASGel, Electrode, For Pulp Tester1Product Code
- EATTester, Pulp2Product Code
- EGZHolder, Film, X-Ray1Product Code
- EHAAligner, Beam, X-Ray1Product Code
- JEOMeasurer, Gingival Fluid1Product Code
- LFCDevice, Caries Detection2Product Code
- K222560BlueCheck™ Caries Detection & Monitoring2Cleared 510(K)
- K200601LumiCare Caries Diagnostic Rinse2Cleared 510(K)
- K193447Vista Dyes2Cleared 510(K)
- K102821DISCOVRED2Cleared 510(K)
- K060330SEE-IT CARIES DETECTOR2Cleared 510(K)
- K030807CARIES INDICATOR2Cleared 510(K)
- K012733CARIES DETECTOR2Cleared 510(K)
- K994368AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS2Cleared 510(K)
- K982105ORAL POTENTIAL METER (OPM)2Cleared 510(K)
- K973200CARIES STAIN2Cleared 510(K)
Show All 17 Submissions
- MVHDevice, Detection, Sulfide2Product Code
- NBLLaser, Fluorescence Caries Detection2Product Code
- NFPDevice, Dental Sonography, For Diagnosis Of Tmj / Mpd Disorders2Product Code
- NFQDevice, Dental Sonography, For Monitoring Jaw Sounds1Product Code
- NFRDevice, Jaw Tracking, For Diagnosis Of Tmj / Mpd Disorders2Product Code
- NFSDevice, Jaw Tracking, For Monitoring Jaw Positions1Product Code
- NTKCaries Detector, Laser Light, Transmission2Product Code
- NYHPlaque Disclosing Kit2Product Code
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
LumiCare Caries Diagnostic Rinse
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K200601
- 510(k) Type
- Traditional
- Applicant
- GreenMark Biomedical Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/29/2021
- Days to Decision
- 385 days
- Submission Type
- Summary