Bonalive Maxillofacial— 510(k) K253883
Substantially EquivalentBonalive , Ltd.
FDA 510(k) clearance K253883 for Bonalive Maxillofacial, Substantially Equivalent on 2026-05-14. Applicant: Bonalive , Ltd.. Device class: 2.
Summary
Bonalive's Bonalive Maxillofacial is filed under LYC, synthetic bone grafting material.
Class II, 21 CFR 872.3930. Dental is both the classification panel and the review panel. It came in as a Special 510(k).
Bonalive filed from Turku, Finland. The decision came 161 calendar days after receipt (December 4, 2025 to May 14, 2026).
Clearance details
- Applicant
- Bonalive , 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
- Special
- Location
- Turku, FI
Recent devices under product code LYC
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