510(k) clearance

One Coat Bond; One Coat Bond SL

FDA 510(k) source

510(k) number

K263680

Applicant

Dent4You AG

Decision date

Oct 8, 2026

Date received

Oct 7, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

KLE

Device type

Agent, Tooth Bonding, Resin

Device class

Class II

Regulation

21 CFR 872.3200

Advisory committee

Dental

Statement or summary

Summary

Third party

Y

Location

Heerbrugg, CH