510(k) K254091
K254091 is an FDA 510(k) premarket notification submitted by YAMAHACHI DENTAL MFG., Co. for the device "GLOSSY COAT (15ML)". The FDA issued a decision of Substantially Equivalent on April 6, 2026. The device falls under product code EBD (Coating, Filling Material, Resin), a Class II device regulated under 21 CFR 872.3310. YAMAHACHI DENTAL MFG., Co. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 6, 2026
- Date Received
- December 19, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coating, Filling Material, Resin
- Device Class
- Class II
- Regulation Number
- 872.3310
- Review Panel
- DE
- Submission Type