Cleared Traditional

K241568 - CrystLCare™ PRO Biorestorative, Fluoride-Plus (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K241568 · GreenMark Biomedical, Inc. · Dental device
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Optimized for regulatory review, auditing and printing
Jan 2025
Decision
216d
Days
Class 2
Risk

K241568 is an FDA 510(k) clearance for the CrystLCare™ PRO Biorestorative, Fluoride-Plus. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by GreenMark Biomedical, Inc. (East Lansing, US). The FDA issued a Cleared decision on January 2, 2025 after a review of 216 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3260 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all GreenMark Biomedical, Inc. devices

Submission Details

510(k) Number K241568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2024
Decision Date January 02, 2025
Days to Decision 216 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 127d · This submission: 216d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LBH Varnish, Cavity
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3260
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Consultant

in2being, LLC
Rick Routson

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LBH Varnish, Cavity

All 136
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K241568.
VOCO Profluorid Varnish + BioMin
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K260830 · Sangi Co, Ltd. · Mar 2026
FluoroDose Varnish
K250714 · Centrix, Inc. · Nov 2025
Rennou™ Varnish (3% / Spearmint)
K243777 · Theodent, LLC · May 2025
ReminGel
K241489 · Inter-Med, Inc. · Jan 2025