BONTREE PLUS— 510(k) K251818
Substantially EquivalentHudens 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.
Summary
Hudens Bio's BONTREE PLUS is filed under LYC, synthetic bone grafting material. The record doesn't list sizes or forms.
Class II, 21 CFR 872.3930. It was a Traditional 510(k), and Dental is both the classification panel and the review panel.
Hudens Bio filed from Gwangju, South Korea. The decision came 266 calendar days after FDA received it (June 13, 2025 to March 6, 2026).
Clearance details
- Applicant
- Hudens Bio Co., Ltd.
- Product code
- Product code LYC
- Device class
- Class 2
- Regulation
- 21 CFR 872.3930
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gwangju, KR
Recent devices under product code LYC
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