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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / September 2025 / K251869

510(k) cleared

Disposable Prophy Angle (3399-60, 3399-090, 3399-105)

Premium Plus (Dongguan) Limited · Sep 15, 2025 · K251869

FDA cleared the Disposable Prophy Angle (3399-60, 3399-090, 3399-105) from Premium Plus (Dongguan) Limited on Sep 15, 2025 under K251869, a traditional 510(k). The device falls under product code EGS, Handpiece, Contra- And Right-Angle Attachment, Dental, regulated at 21 CFR 872.4200 as a Class 1 device. The review panel was Dental.

FDA logged the submission as received on Jun 18, 2025. The decision came 89 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Premium Plus (Dongguan) Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251869?

K251869 is the FDA 510(k) for Disposable Prophy Angle (3399-60, 3399-090, 3399-105), submitted by Premium Plus (Dongguan) Limited. FDA's decision date was Sep 15, 2025, under product code EGS (Handpiece, Contra- And Right-Angle Attachment, Dental).

Who makes the Disposable Prophy Angle (3399-60, 3399-090, 3399-105)?

Premium Plus (Dongguan) Limited, based in Dongguan, is the applicant of record for K251869.

How long did the K251869 review take?

FDA received the submission on Jun 18, 2025 and issued its decision on Sep 15, 2025, 89 days later.

← All decisions in September 2025