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FDA 510(k)

MALTA

K-Number: K100756 · 2010-06-02

Applicant3M Espe AG Dental Products
Decision Date2010-06-02
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MALTA is the device name listed in this FDA 510(k) record. The listed applicant is 3M Espe AG Dental Products. It received FDA 510(k) clearance on 2010-06-02 under 510(k) number K100756. 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 MALTA?

MALTA is a medical device that received FDA 510(k) clearance on 2010-06-02. The listed applicant is 3M Espe AG Dental Products. The 510(k) number is K100756.

When did MALTA receive FDA 510(k) clearance?

MALTA received FDA 510(k) clearance on 2010-06-02, under 510(k) number K100756.

Who is the listed applicant for MALTA?

The FDA 510(k) record lists 3M Espe AG Dental Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MALTA?

The FDA product code for MALTA is EMA.

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Other records listing 3M Espe AG Dental Products 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.

K100908UNICEM HMK094007UNICEMK093721COSP2K091826ELEGANTK090718BELLUS SHADING KITK080514PECD-01 AND PECD QUICK-01

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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

View on FDA Database →

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

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