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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 / December 2025 / K252090

510(k) cleared

Pterygoid Indication for GM Helix Implants

JJGC Indústria e Comércio de Materiais Dentários S.A. · Dec 12, 2025 · K252090

FDA cleared the Pterygoid Indication for GM Helix Implants from JJGC Indústria e Comércio de Materiais Dentários S.A. on Dec 12, 2025 under K252090, a traditional 510(k). The device falls under product code DZE, Implant, Endosseous, Root-Form, regulated at 21 CFR 872.3640 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jul 2, 2025. The decision came 163 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

JJGC Indústria e Comércio de Materiais Dentários S.A. has 3 other decisions in the tracker over the last 12 months: K261147 (Neodent Implant System - NeoConvert Fit), K253922 (Neodent Scannable Healing Abutment), K252727 (Neodent InLab Validated Workflow).

Questions & Answers

What did FDA clear under K252090?

K252090 is the FDA 510(k) for Pterygoid Indication for GM Helix Implants, submitted by JJGC Indústria e Comércio de Materiais Dentários S.A.. FDA's decision date was Dec 12, 2025, under product code DZE (Implant, Endosseous, Root-Form).

Who makes the Pterygoid Indication for GM Helix Implants?

JJGC Indústria e Comércio de Materiais Dentários S.A., based in Curitiba, is the applicant of record for K252090.

How long did the K252090 review take?

FDA received the submission on Jul 2, 2025 and issued its decision on Dec 12, 2025, 163 days later.

← All decisions in December 2025

Sources