510(k) K241568
K241568 is an FDA 510(k) premarket notification submitted by GreenMark Biomedical, Inc. for the device "CrystLCare PRO Biorestorative, Fluoride-Plus". The FDA issued a decision of Substantially Equivalent on January 2, 2025. The device falls under product code LBH (Varnish, Cavity), a Class II device regulated under 21 CFR 872.3260. GreenMark Biomedical, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 2, 2025
- Date Received
- May 31, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Varnish, Cavity
- Device Class
- Class II
- Regulation Number
- 872.3260
- Review Panel
- DE
- Submission Type