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THE TAPE

FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

The Tracker / September 2026 / K262202

510(k) cleared

Cerasmart Forte

GC America, Inc. · Sep 10, 2026 · K262202

FDA cleared the Cerasmart Forte from GC America, Inc. on Sep 10, 2026 under K262202, a traditional 510(k). The device falls under product code EBF, Material, Tooth Shade, Resin, regulated at 21 CFR 872.3690 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jun 29, 2026. The decision came 73 days later, inside the 90 FDA-day goal for a 510(k).

GC America, Inc. has 8 other decisions in the tracker over the last 12 months: K262828 (KHEIRON® Spinal Fixation System, including patient specific K-ROD), DEN250043 (Qoramatic Automated Stool Management), K261500 (KBA3D (v2.4.0)), K253808 (AIR Recon DL).

Questions & Answers

What did FDA clear under K262202?

K262202 is the FDA 510(k) for Cerasmart Forte, submitted by GC America, Inc.. FDA's decision date was Sep 10, 2026, under product code EBF (Material, Tooth Shade, Resin).

Who makes the Cerasmart Forte?

GC America, Inc., based in Alsip, IL, is the applicant of record for K262202.

How long did the K262202 review take?

FDA received the submission on Jun 29, 2026 and issued its decision on Sep 10, 2026, 73 days later.

← All decisions in September 2026