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FDA 510(k)

Bonalive Maxillofacial

K-Number: K253883 · 2026-05-14

ApplicantBonalive , Ltd.
Decision Date2026-05-14
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Bonalive Maxillofacial is a medical device manufactured by Bonalive , Ltd.. It received FDA 510(k) clearance on 2026-05-14 under approval number K253883. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bonalive Maxillofacial?

Bonalive Maxillofacial is a medical device that received FDA 510(k) clearance on 2026-05-14. It is manufactured by Bonalive , Ltd.. The 510(k) number is K253883.

When was Bonalive Maxillofacial approved by the FDA?

Bonalive Maxillofacial received FDA 510(k) clearance on 2026-05-14, under approval number K253883.

What company makes Bonalive Maxillofacial?

Bonalive Maxillofacial is manufactured by Bonalive , Ltd..

What is the FDA product code for Bonalive Maxillofacial?

The FDA product code for Bonalive Maxillofacial is LYC.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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