Cleared Traditional

K263680 - One Coat Bond

Also marketed or referenced as:
One Coat Bond SL

K263680 is an FDA 510(k) clearance for One Coat Bond, manufactured by Dent4you AG. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 1-day FDA review.

K263680 · Dent4you AG · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
1d
Days
Class 2
Risk

K263680 is an FDA 510(k) clearance for the One Coat Bond. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Dent4you AG (Heerbrugg, CH). The FDA issued a Cleared decision on October 8, 2026 after a review of 1 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K263680

510(k) Number K263680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2026
Decision Date October 08, 2026
Days to Decision 1 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
127d faster than avg
Panel avg: 128d · This submission: 1d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

KLE Device Classification - Class 2, Special Controls

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Consultant

Regulatory Technology Services, LLC
Prithul Bom

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KLE Agent, Tooth Bonding, Resin

All 418
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K263680.
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K252450 · Ivoclar Vivadent, Inc. · Mar 2026
Bond-PR™ Universal Adhesive
K260682 · Premier Dental Products Company · Mar 2026
VITA VMLC Primer
K251587 · Vita Zahnfabrik H. Rauter GmbH & Co. Kg. · Feb 2026
K263680 · One Coat Bond
Download PDF FDA Summary Dent4you AG