WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

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 / March 2026 / K252168

510(k) cleared

Straumann® BLC Implants - Indication Widening

Institut Straumann AG · Mar 10, 2026 · K252168

FDA cleared the Straumann® BLC Implants - Indication Widening from Institut Straumann AG on Mar 10, 2026 under K252168, 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 10, 2025. The decision came 243 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), K253315 (Straumann Variobase Abutments XC for Bridge/Bar).

Questions & Answers

What did FDA clear under K252168?

K252168 is the FDA 510(k) for Straumann® BLC Implants - Indication Widening, submitted by Institut Straumann AG. FDA's decision date was Mar 10, 2026, under product code DZE (Implant, Endosseous, Root-Form).

Who makes the Straumann® BLC Implants - Indication Widening?

Institut Straumann AG, based in Basel, is the applicant of record for K252168.

How long did the K252168 review take?

FDA received the submission on Jul 10, 2025 and issued its decision on Mar 10, 2026, 243 days later.

← All decisions in March 2026

Sources