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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 / June 2026 / K260569

510(k) cleared

DB 4000 High Impact Denture Base

Carbon, Inc. · Jun 2, 2026 · K260569

FDA cleared the DB 4000 High Impact Denture Base from Carbon, Inc. on Jun 2, 2026 under K260569, a abbreviated 510(k). The device falls under product code EBI, Resin, Denture, Relining, Repairing, Rebasing, regulated at 21 CFR 872.3760 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Feb 19, 2026. The decision came 103 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Carbon, Inc. has one other decision in the tracker over the last 12 months: K253598 (InjecSURE Injection System).

Questions & Answers

What did FDA clear under K260569?

K260569 is the FDA 510(k) for DB 4000 High Impact Denture Base, submitted by Carbon, Inc.. FDA's decision date was Jun 2, 2026, under product code EBI (Resin, Denture, Relining, Repairing, Rebasing).

Who makes the DB 4000 High Impact Denture Base?

Carbon, Inc., based in Sunnyvale, CA, is the applicant of record for K260569.

How long did the K260569 review take?

FDA received the submission on Feb 19, 2026 and issued its decision on Jun 2, 2026, 103 days later.

← All decisions in June 2026

Sources