Cleared Traditional

CrystLCare? PRO Biorestorative, Fluoride-Plus

K241568 · GreenMark Biomedical, Inc. · Dental

Jan 2025

Decision

216d

Days

Class 2

Risk

About This 510(k) Submission

K241568 is an FDA 510(k) clearance for the CrystLCare? PRO Biorestorative, Fluoride-Plus, a Varnish, Cavity (Class II — Special Controls, product code LBH), submitted by GreenMark Biomedical, Inc. (East Lansing, US). The FDA issued a Cleared decision on January 2, 2025, 216 days after receiving the submission on May 31, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number	K241568 FDA.gov
FDA Decision	Cleared 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