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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 / K260029

510(k) cleared

Firstar Dental Handpieces

FDC Technology Industry Co. · Oct 1, 2026 · K260029

FDA cleared the Firstar Dental Handpieces from FDC Technology Industry Co. on Oct 1, 2026 under K260029, a traditional 510(k). The device falls under product code EFB, Handpiece, Air-Powered, Dental, regulated at 21 CFR 872.4200 as a Class 1 device. The review panel was Dental.

FDA logged the submission as received on Jan 5, 2026. The decision came 269 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

FDC Technology Industry Co. has one other decision in the tracker over the last 12 months: K260027 (Firstar Dental Electric Motor).

Questions & Answers

What did FDA clear under K260029?

K260029 is the FDA 510(k) for Firstar Dental Handpieces, submitted by FDC Technology Industry Co.. FDA's decision date was Oct 1, 2026, under product code EFB (Handpiece, Air-Powered, Dental).

Who makes the Firstar Dental Handpieces?

FDC Technology Industry Co., based in Kent, WA, is the applicant of record for K260029.

How long did the K260029 review take?

FDA received the submission on Jan 5, 2026 and issued its decision on Oct 1, 2026, 269 days later.

← All decisions in October 2026

Sources