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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 / January 2026 / K253315

510(k) cleared

Straumann Variobase Abutments XC for Bridge/Bar

Institut Straumann AG · Jan 22, 2026 · K253315

FDA cleared the Straumann Variobase Abutments XC for Bridge/Bar from Institut Straumann AG on Jan 22, 2026 under K253315, 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 Sep 30, 2025. The decision came 114 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Institut Straumann AG has 3 other decisions in the tracker over the last 12 months: K260726 (Straumann® ProClean Cassette (041.800 ; 041.801)), K260460 (Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue), K252168 (Straumann® BLC Implants - Indication Widening).

Questions & Answers

What did FDA clear under K253315?

K253315 is the FDA 510(k) for Straumann Variobase Abutments XC for Bridge/Bar, submitted by Institut Straumann AG. FDA's decision date was Jan 22, 2026, under product code NHA (Abutment, Implant, Dental, Endosseous).

Who makes the Straumann Variobase Abutments XC for Bridge/Bar?

Institut Straumann AG, based in Basel, is the applicant of record for K253315.

How long did the K253315 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Jan 22, 2026, 114 days later.

← All decisions in January 2026

Sources