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Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries

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 one other decision in the tracker over the last 12 months: 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