510(k) K263680
K263680 is an FDA 510(k) premarket notification submitted by Dent4You AG for the device "One Coat Bond; One Coat Bond SL". The FDA issued a decision of Substantially Equivalent on Oct 8, 2026. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200. Dent4You AG has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 8, 2026
- Date Received
- Oct 7, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Agent, Tooth Bonding, Resin
- Device Class
- Class II
- Regulation Number
- 872.3200
- Review Panel
- DE
- Submission Type
- 510(k)