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GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter

The Tracker / October 2026 / K260275

510(k) cleared

Mobile Dental Solution (Model: DS50, DS70, DS90)

Guangdong JINME Medical Technology Co., Ltd. · Oct 23, 2026 · K260275

FDA cleared the Mobile Dental Solution (Model: DS50, DS70, DS90) from Guangdong JINME Medical Technology Co., Ltd. on Oct 23, 2026 under K260275, a traditional 510(k). The device falls under product code EIA, Unit, Operative Dental, regulated at 21 CFR 872.6640 as a Class 1 device. The review panel was Dental.

FDA logged the submission as received on Jan 29, 2026. The decision came 267 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Guangdong JINME Medical Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260275?

K260275 is the FDA 510(k) for Mobile Dental Solution (Model: DS50, DS70, DS90), submitted by Guangdong JINME Medical Technology Co., Ltd.. FDA's decision date was Oct 23, 2026, under product code EIA (Unit, Operative Dental).

Who makes the Mobile Dental Solution (Model: DS50, DS70, DS90)?

Guangdong JINME Medical Technology Co., Ltd., based in Foshan, is the applicant of record for K260275.

How long did the K260275 review take?

FDA received the submission on Jan 29, 2026 and issued its decision on Oct 23, 2026, 267 days later.

← All decisions in October 2026