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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 / May 2026 / K254109

510(k) cleared

G-CEM UNIVERSAL

GC America, Inc. · May 18, 2026 · K254109

FDA cleared the G-CEM UNIVERSAL from GC America, Inc. on May 18, 2026 under K254109, a traditional 510(k). The device falls under product code EMA, Cement, Dental, regulated at 21 CFR 872.3275 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Dec 19, 2025. The decision came 150 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

GC America, Inc. has 8 other decisions in the tracker over the last 12 months: K261217 (AnyPlus II Spinal Fixation System), K254302 (ECG Analysis Software (AiTiALVSD)), K260250 (QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)), K243223 (Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)).

Questions & Answers

What did FDA clear under K254109?

K254109 is the FDA 510(k) for G-CEM UNIVERSAL, submitted by GC America, Inc.. FDA's decision date was May 18, 2026, under product code EMA (Cement, Dental).

Who makes the G-CEM UNIVERSAL?

GC America, Inc., based in Alsip, IL, is the applicant of record for K254109.

How long did the K254109 review take?

FDA received the submission on Dec 19, 2025 and issued its decision on May 18, 2026, 150 days later.

← All decisions in May 2026