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FDA 510(k)

AHL GENERIC GLASS IONOMER LUTING CEMENT

K-Number: K023981 · 2003-01-31

ApplicantAdvanced Healthcare , Ltd.
Decision Date2003-01-31
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AHL GENERIC GLASS IONOMER LUTING 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 2003-01-31 under 510(k) number K023981. 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 AHL GENERIC GLASS IONOMER LUTING CEMENT?

AHL GENERIC GLASS IONOMER LUTING CEMENT is a medical device that received FDA 510(k) clearance on 2003-01-31. The listed applicant is Advanced Healthcare , Ltd.. The 510(k) number is K023981.

When did AHL GENERIC GLASS IONOMER LUTING CEMENT receive FDA 510(k) clearance?

AHL GENERIC GLASS IONOMER LUTING CEMENT received FDA 510(k) clearance on 2003-01-31, under 510(k) number K023981.

Who is the listed applicant for AHL GENERIC GLASS IONOMER LUTING 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 AHL GENERIC GLASS IONOMER LUTING CEMENT?

The FDA product code for AHL GENERIC GLASS IONOMER LUTING 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.

K024287FIXOBRIDGE 3-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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