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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is GreenMark Biomedical, Inc.. It received FDA 510(k) clearance on 2025-01-02 under 510(k) 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. The listed applicant is GreenMark Biomedical, Inc.. The 510(k) number is K241568.

When did CrystLCare™ PRO Biorestorative, Fluoride-Plus receive FDA 510(k) clearance?

CrystLCare™ PRO Biorestorative, Fluoride-Plus received FDA 510(k) clearance on 2025-01-02, under 510(k) number K241568.

Who is the listed applicant for CrystLCare™ PRO Biorestorative, Fluoride-Plus?

The FDA 510(k) record lists GreenMark Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing GreenMark Biomedical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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