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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 / October 2025 / K252870

510(k) cleared

Invisalign Specifix Attachment System

Align Technology, Inc. · Oct 9, 2025 · K252870

FDA cleared the Invisalign Specifix Attachment System from Align Technology, Inc. on Oct 9, 2025 under K252870, a special 510(k). The device falls under product code NXC, Aligner, Sequential, regulated at 21 CFR 872.5470 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Sep 9, 2025. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

Align Technology, Inc. has 2 other decisions in the tracker over the last 12 months: K261847 (iTero Lumina Pro), K252931 (Invisalign® Palatal Expander System).

Questions & Answers

What did FDA clear under K252870?

K252870 is the FDA 510(k) for Invisalign Specifix Attachment System, submitted by Align Technology, Inc.. FDA's decision date was Oct 9, 2025, under product code NXC (Aligner, Sequential).

Who makes the Invisalign Specifix Attachment System?

Align Technology, Inc., based in San Jose, CA, is the applicant of record for K252870.

How long did the K252870 review take?

FDA received the submission on Sep 9, 2025 and issued its decision on Oct 9, 2025, 30 days later.

← All decisions in October 2025

Sources