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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 / July 2026 / K261147

510(k) cleared

Neodent Implant System - NeoConvert Fit

JJGC Indústria e Comércio de Materiais Dentários S.A. · Jul 1, 2026 · K261147

FDA cleared the Neodent Implant System - NeoConvert Fit from JJGC Indústria e Comércio de Materiais Dentários S.A. on Jul 1, 2026 under K261147, a traditional 510(k). The device falls under product code NHA, Abutment, Implant, Dental, Endosseous, regulated at 21 CFR 872.3630 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Apr 7, 2026. The decision came 85 days later, inside the 90 FDA-day goal for a 510(k).

JJGC Indústria e Comércio de Materiais Dentários S.A. has 3 other decisions in the tracker over the last 12 months: K253922 (Neodent Scannable Healing Abutment), K252727 (Neodent InLab Validated Workflow), K252090 (Pterygoid Indication for GM Helix Implants).

Questions & Answers

What did FDA clear under K261147?

K261147 is the FDA 510(k) for Neodent Implant System - NeoConvert Fit, submitted by JJGC Indústria e Comércio de Materiais Dentários S.A.. FDA's decision date was Jul 1, 2026, under product code NHA (Abutment, Implant, Dental, Endosseous).

Who makes the Neodent Implant System - NeoConvert Fit?

JJGC Indústria e Comércio de Materiais Dentários S.A., based in Curitiba, is the applicant of record for K261147.

How long did the K261147 review take?

FDA received the submission on Apr 7, 2026 and issued its decision on Jul 1, 2026, 85 days later.

← All decisions in July 2026

Sources