One Coat Bond; One Coat Bond SL— 510(k) K263680
Substantially EquivalentDent4You AG
FDA 510(k) clearance K263680 for One Coat Bond; One Coat Bond SL, Substantially Equivalent on 2026-10-08. Applicant: Dent4You AG. Device class: 2.
Summary
One Coat Bond and One Coat Bond SL are resin tooth bonding agents from Dent4You, filed under KLE. The record doesn't say how the two versions differ.
Class II, 21 CFR 872.3200. The Dental panel reviewed it as a Traditional 510(k).
Dent4You filed from Heerbrugg, Switzerland. The record shows a received date of October 7, 2026 and a decision on October 8, a one-day clock. The record flags it as a third-party review.
Clearance details
- Applicant
- Dent4You AG
- Product code
- Product code KLE
- Device class
- Class 2
- Regulation
- 21 CFR 872.3200
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Heerbrugg, CH
Recent devices under product code KLE
view allMore clearances from Dent4You AG
view allData sourced from openFDA. This site is unofficial and independent of the FDA.