BONTREE PLUS— 510(k) K251818

Substantially Equivalent

Hudens Bio Co., Ltd.

FDA 510(k) clearance K251818 for BONTREE PLUS, Substantially Equivalent on 2026-03-06. Applicant: Hudens Bio Co., Ltd.. Device class: 2.

Clearance details

Applicant: Hudens Bio Co., Ltd.
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2025-06-13
Decision date: 2026-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gwangju, KR

Download summary PDF View on FDA.gov ↗

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