FDA 510(k)

Bonalive Maxillofacial

K-Number: K253883 · 2026-05-14

Decision Date2026-05-14

Product CodeLYC

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Bonalive Maxillofacial is the device name listed in this FDA 510(k) record. The listed applicant is Bonalive , Ltd.. It received FDA 510(k) clearance on 2026-05-14 under 510(k) 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. The listed applicant is Bonalive , Ltd.. The 510(k) number is K253883.

When did Bonalive Maxillofacial receive FDA 510(k) clearance?

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

Who is the listed applicant for Bonalive Maxillofacial?

The FDA 510(k) record lists Bonalive , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bonalive Maxillofacial?

The FDA product code for Bonalive Maxillofacial is LYC.

Related Devices (Code: LYC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.