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The Tracker / August 2026 / K254286

510(k) cleared

Guided Bone Regeneration System

DentalMaster(Xiamen)Medical Technology Co., Ltd. · Aug 24, 2026 · K254286

FDA cleared the Guided Bone Regeneration System from DentalMaster(Xiamen)Medical Technology Co., Ltd. on Aug 24, 2026 under K254286, a traditional 510(k). The device falls under product code DZL, Screw, Fixation, Intraosseous, regulated at 21 CFR 872.4880 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Dec 31, 2025. The decision came 236 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 DentalMaster(Xiamen)Medical Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254286?

K254286 is the FDA 510(k) for Guided Bone Regeneration System, submitted by DentalMaster(Xiamen)Medical Technology Co., Ltd.. FDA's decision date was Aug 24, 2026, under product code DZL (Screw, Fixation, Intraosseous).

Who makes the Guided Bone Regeneration System?

DentalMaster(Xiamen)Medical Technology Co., Ltd., based in Xiamen, is the applicant of record for K254286.

How long did the K254286 review take?

FDA received the submission on Dec 31, 2025 and issued its decision on Aug 24, 2026, 236 days later.

← All decisions in August 2026