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FDA 510(k)

FIXOBRIDGE 3-CEMENT

K-Number: K024287 · 2003-03-21

ApplicantAdvanced Healthcare , Ltd.
Decision Date2003-03-21
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FIXOBRIDGE 3-CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Healthcare , Ltd.. It received FDA 510(k) clearance on 2003-03-21 under 510(k) number K024287. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIXOBRIDGE 3-CEMENT?

FIXOBRIDGE 3-CEMENT is a medical device that received FDA 510(k) clearance on 2003-03-21. The listed applicant is Advanced Healthcare , Ltd.. The 510(k) number is K024287.

When did FIXOBRIDGE 3-CEMENT receive FDA 510(k) clearance?

FIXOBRIDGE 3-CEMENT received FDA 510(k) clearance on 2003-03-21, under 510(k) number K024287.

Who is the listed applicant for FIXOBRIDGE 3-CEMENT?

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

What is the FDA product code for FIXOBRIDGE 3-CEMENT?

The FDA product code for FIXOBRIDGE 3-CEMENT is EMA.

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Other records listing Advanced Healthcare , Ltd. as applicant

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.

K023981AHL GENERIC GLASS IONOMER LUTING CEMENTK020376AHL GENERIC GLASS IONOMER AESTHETIC RESTORATIVE

Related Devices (Code: EMA)

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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.

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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