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The Tracker / August 2026 / K260463

510(k) cleared

ZEROS Dental Implant System

Zeros Co., Ltd. · Aug 19, 2026 · K260463

FDA cleared the ZEROS Dental Implant System from Zeros Co., Ltd. on Aug 19, 2026 under K260463, a special 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 Feb 12, 2026. The decision came 188 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Zeros Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260463?

K260463 is the FDA 510(k) for ZEROS Dental Implant System, submitted by Zeros Co., Ltd.. FDA's decision date was Aug 19, 2026, under product code DZE (Implant, Endosseous, Root-Form).

Who makes the ZEROS Dental Implant System?

Zeros Co., Ltd., based in Gyeongsangnam-Do, is the applicant of record for K260463.

How long did the K260463 review take?

FDA received the submission on Feb 12, 2026 and issued its decision on Aug 19, 2026, 188 days later.

← All decisions in August 2026