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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 / January 2026 / K260170

510(k) cleared

LumiCera

Hangzhou SHINING3D Dental Technology Co., Ltd. · Jan 21, 2026 · K260170

FDA cleared the LumiCera from Hangzhou SHINING3D Dental Technology Co., Ltd. on Jan 21, 2026 under K260170, a traditional 510(k) reviewed through the Third Party Review Program. 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 Jan 20, 2026. The decision came 1 days later, inside the 90 FDA-day goal for a 510(k).

Hangzhou SHINING3D Dental Technology Co., Ltd. has 2 other decisions in the tracker over the last 12 months: K261356 (Dura-Crown), K261261 (Dura-Arch).

Questions & Answers

What did FDA clear under K260170?

K260170 is the FDA 510(k) for LumiCera, submitted by Hangzhou SHINING3D Dental Technology Co., Ltd.. FDA's decision date was Jan 21, 2026, under product code EBF (Material, Tooth Shade, Resin).

Who makes the LumiCera?

Hangzhou SHINING3D Dental Technology Co., Ltd., based in Hangzhou, is the applicant of record for K260170.

How long did the K260170 review take?

FDA received the submission on Jan 20, 2026 and issued its decision on Jan 21, 2026, 1 days later.

← All decisions in January 2026

Sources