510(k) K261404
K261404 is an FDA 510(k) premarket notification submitted by Ultradent Products, Inc. for the device "UltraEZ". The FDA issued a decision of Substantially Equivalent on April 30, 2026. The device falls under product code LBH (Varnish, Cavity), a Class II device regulated under 21 CFR 872.3260. Ultradent Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 30, 2026
- Date Received
- April 29, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Varnish, Cavity
- Device Class
- Class II
- Regulation Number
- 872.3260
- Review Panel
- DE
- Submission Type