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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / October 2026 / K263680

510(k) cleared

One Coat Bond; One Coat Bond SL

Dent4You AG · Oct 8, 2026 · K263680

FDA cleared the One Coat Bond; One Coat Bond SL from Dent4You AG on Oct 8, 2026 under K263680, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code KLE, Agent, Tooth Bonding, Resin, regulated at 21 CFR 872.3200 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Oct 7, 2026. The decision came 1 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Dent4You AG in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K263680?

K263680 is the FDA 510(k) for One Coat Bond; One Coat Bond SL, submitted by Dent4You AG. FDA's decision date was Oct 8, 2026, under product code KLE (Agent, Tooth Bonding, Resin).

Who makes the One Coat Bond; One Coat Bond SL?

Dent4You AG, based in Heerbrugg, is the applicant of record for K263680.

How long did the K263680 review take?

FDA received the submission on Oct 7, 2026 and issued its decision on Oct 8, 2026, 1 days later.

← All decisions in October 2026