Bonalive Maxillofacial— 510(k) K253883

Substantially Equivalent

Bonalive , Ltd.

FDA 510(k) clearance K253883 for Bonalive Maxillofacial, Substantially Equivalent on 2026-05-14. Applicant: Bonalive , Ltd.. Device class: 2.

Clearance details

Applicant: Bonalive , Ltd.
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2025-12-04
Decision date: 2026-05-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Turku, FI

Download summary PDF View on FDA.gov ↗

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