MEDIUMRegulatoryTier 1
FDA 510(k) K263680: One Coat Bond; One Coat Bond SL
Summary & scoring by The Bell Brief (Dr. Jennifer Bell) using the Drill-Down Protocol (Drill-Down Score) — not the original publisher.
Why it matters for dental
Dent4You AG received FDA clearance for One Coat Bond and One Coat Bond SL, allowing U.S. dental practices to add these Class II resin bonding agents to their adhesive inventory under product code KLE.
Key points
- Dent4You AG obtained 510(k) clearance K263680 for One Coat Bond and One Coat Bond SL as substantially equivalent devices.
- Both products are classified as Class II tooth-bonding resin agents under regulation 872.3200.
- FDA clearance permits U.S. dental practices to purchase and use these adhesives without additional premarket approval.
Who should care
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Read the original on openFDA Dental Devices
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