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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 / April 2026 / K260430

510(k) cleared

Porcelain Etch Gel

Belport Company, Inc., Gingi-Pak · Apr 10, 2026 · K260430

FDA cleared the Porcelain Etch Gel from Belport Company, Inc., Gingi-Pak on Apr 10, 2026 under K260430, a traditional 510(k). The device falls under product code KLE, Agent, Tooth Bonding, Resin, regulated at 21 CFR 872.3200 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Feb 10, 2026. The decision came 59 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Belport Company, Inc., Gingi-Pak in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260430?

K260430 is the FDA 510(k) for Porcelain Etch Gel, submitted by Belport Company, Inc., Gingi-Pak. FDA's decision date was Apr 10, 2026, under product code KLE (Agent, Tooth Bonding, Resin).

Who makes the Porcelain Etch Gel?

Belport Company, Inc., Gingi-Pak, based in Camarillo, CA, is the applicant of record for K260430.

How long did the K260430 review take?

FDA received the submission on Feb 10, 2026 and issued its decision on Apr 10, 2026, 59 days later.

← All decisions in April 2026