510(k) K250714
K250714 is an FDA 510(k) premarket notification submitted by Centrix, Inc. for the device "FluoroDose Varnish". The FDA issued a decision of Substantially Equivalent on November 21, 2025. The device falls under product code LBH (Varnish, Cavity), a Class II device regulated under 21 CFR 872.3260. Centrix, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 21, 2025
- Date Received
- March 10, 2025
- 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