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THE TAPE

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 / January 2026 / K252727

510(k) cleared

Neodent InLab Validated Workflow

JJGC Indústria e Comércio de Materiais Dentários S.A. · Jan 7, 2026 · K252727

FDA cleared the Neodent InLab Validated Workflow from JJGC Indústria e Comércio de Materiais Dentários S.A. on Jan 7, 2026 under K252727, 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 Aug 28, 2025. The decision came 132 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), K252090 (Pterygoid Indication for GM Helix Implants).

Questions & Answers

What did FDA clear under K252727?

K252727 is the FDA 510(k) for Neodent InLab Validated Workflow, submitted by JJGC Indústria e Comércio de Materiais Dentários S.A.. FDA's decision date was Jan 7, 2026, under product code NHA (Abutment, Implant, Dental, Endosseous).

Who makes the Neodent InLab Validated Workflow?

JJGC Indústria e Comércio de Materiais Dentários S.A., based in Curitiba, is the applicant of record for K252727.

How long did the K252727 review take?

FDA received the submission on Aug 28, 2025 and issued its decision on Jan 7, 2026, 132 days later.

← All decisions in January 2026

Sources