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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 / May 2026 / K260460

510(k) cleared

Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue

Institut Straumann AG · May 7, 2026 · K260460

FDA cleared the Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue from Institut Straumann AG on May 7, 2026 under K260460, 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 Feb 11, 2026. The decision came 85 days later, inside the 90 FDA-day goal for a 510(k).

Institut Straumann AG has 3 other decisions in the tracker over the last 12 months: K260726 (Straumann® ProClean Cassette (041.800 ; 041.801)), K252168 (Straumann® BLC Implants - Indication Widening), K253315 (Straumann Variobase Abutments XC for Bridge/Bar).

Questions & Answers

What did FDA clear under K260460?

K260460 is the FDA 510(k) for Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue, submitted by Institut Straumann AG. FDA's decision date was May 7, 2026, under product code NHA (Abutment, Implant, Dental, Endosseous).

Who makes the Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue?

Institut Straumann AG, based in Basal, is the applicant of record for K260460.

How long did the K260460 review take?

FDA received the submission on Feb 11, 2026 and issued its decision on May 7, 2026, 85 days later.

← All decisions in May 2026

Sources