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FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first

The Tracker / September 2026 / K262982

510(k) cleared

Core·it Dual

Spident Co., Ltd. · Sep 21, 2026 · K262982

FDA cleared the Core·it Dual from Spident Co., Ltd. on Sep 21, 2026 under K262982, a special 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 Aug 27, 2026. The decision came 25 days later, inside the 90 FDA-day goal for a 510(k).

Spident Co., Ltd. has 3 other decisions in the tracker over the last 12 months: K262983 (EsTemp Implant), K262050 (Vioseal X), K261129 (OrthoFit).

Questions & Answers

What did FDA clear under K262982?

K262982 is the FDA 510(k) for Core·it Dual, submitted by Spident Co., Ltd.. FDA's decision date was Sep 21, 2026, under product code EBF (Material, Tooth Shade, Resin).

Who makes the Core·it Dual?

Spident Co., Ltd., based in Incheon, is the applicant of record for K262982.

How long did the K262982 review take?

FDA received the submission on Aug 27, 2026 and issued its decision on Sep 21, 2026, 25 days later.

← All decisions in September 2026

Sources