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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 / August 2026 / K261514

510(k) cleared

Calcium Hydroxide Temporary Filling Material (KP-Cal)

Guilin Kevin Peter Technology Co., Ltd. · Aug 25, 2026 · K261514

FDA cleared the Calcium Hydroxide Temporary Filling Material (KP-Cal) from Guilin Kevin Peter Technology Co., Ltd. on Aug 25, 2026 under K261514, a traditional 510(k). The device falls under product code KIF, Resin, Root Canal Filling, regulated at 21 CFR 872.3820 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on May 7, 2026. The decision came 110 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Guilin Kevin Peter Technology Co., Ltd. has 3 other decisions in the tracker over the last 12 months: K261047 (Dental Diode Laser Device (Laser-Pen)), K261695 (Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)), K261415 (Injectable Root Canal Sealer (KP-Root SP)).

Questions & Answers

What did FDA clear under K261514?

K261514 is the FDA 510(k) for Calcium Hydroxide Temporary Filling Material (KP-Cal), submitted by Guilin Kevin Peter Technology Co., Ltd.. FDA's decision date was Aug 25, 2026, under product code KIF (Resin, Root Canal Filling).

Who makes the Calcium Hydroxide Temporary Filling Material (KP-Cal)?

Guilin Kevin Peter Technology Co., Ltd., based in Guilin, is the applicant of record for K261514.

How long did the K261514 review take?

FDA received the submission on May 7, 2026 and issued its decision on Aug 25, 2026, 110 days later.

← All decisions in August 2026

Sources