Guided Bone Regeneration System— 510(k) K254286

Name: FDA 510(k) clearance K254286
Creator: U.S. Food and Drug Administration
Published: 2026-08-24

Substantially Equivalent

DentalMaster(Xiamen)Medical Technology Co., Ltd.

FDA 510(k) clearance K254286 for Guided Bone Regeneration System, Substantially Equivalent on 2026-08-24. Applicant: DentalMaster(Xiamen)Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: DentalMaster(Xiamen)Medical Technology Co., Ltd.
Product code: Code DZL
Device class: Class 2
Regulation: 21 CFR 872.4880
Advisory panel: Dental
Date received: 2025-12-31
Decision date: 2026-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xiamen, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZL

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K250123 — Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)2025-09-29
K251569 — Bone Screw2025-08-13
K243190 — USTOMED Bone Fixation/Bone Augmentation Systems - PIN2025-06-27
K233419 — GBR System2025-01-03
K240321 — MP Pin flat without thread (36BMP000020/MP20)2024-10-17

Adverse events under product code DZL

product code DZL

Injury: 168
Total: 168

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.