CrystLCare PRO Biorestorative, Fluoride-Plus
K-Number: K241568 · 2025-01-02
ApplicantGreenMark Biomedical, Inc.
Decision Date2025-01-02
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
CrystLCare PRO Biorestorative, Fluoride-Plus is a medical device manufactured by GreenMark Biomedical, Inc.. It received FDA 510(k) clearance on 2025-01-02 under approval number K241568. The device is classified under product code LBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CrystLCare PRO Biorestorative, Fluoride-Plus?
CrystLCare PRO Biorestorative, Fluoride-Plus is a medical device that received FDA 510(k) clearance on 2025-01-02. It is manufactured by GreenMark Biomedical, Inc.. The 510(k) number is K241568.
When was CrystLCare PRO Biorestorative, Fluoride-Plus approved by the FDA?
CrystLCare PRO Biorestorative, Fluoride-Plus received FDA 510(k) clearance on 2025-01-02, under approval number K241568.
What company makes CrystLCare PRO Biorestorative, Fluoride-Plus?
CrystLCare PRO Biorestorative, Fluoride-Plus is manufactured by GreenMark Biomedical, Inc..
What is the FDA product code for CrystLCare PRO Biorestorative, Fluoride-Plus?
The FDA product code for CrystLCare PRO Biorestorative, Fluoride-Plus is LBH.
Other Devices by GreenMark Biomedical, Inc.
Related Devices (Code: LBH)
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.