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FDA 510(k)

VITRO MOLAR

K-Number: K123826 · 2013-02-14

ApplicantDfl Industria E Comercio SA
Decision Date2013-02-14
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VITRO MOLAR is the device name listed in this FDA 510(k) record. The listed applicant is Dfl Industria E Comercio SA. It received FDA 510(k) clearance on 2013-02-14 under 510(k) number K123826. 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 VITRO MOLAR?

VITRO MOLAR is a medical device that received FDA 510(k) clearance on 2013-02-14. The listed applicant is Dfl Industria E Comercio SA. The 510(k) number is K123826.

When did VITRO MOLAR receive FDA 510(k) clearance?

VITRO MOLAR received FDA 510(k) clearance on 2013-02-14, under 510(k) number K123826.

Who is the listed applicant for VITRO MOLAR?

The FDA 510(k) record lists Dfl Industria E Comercio SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITRO MOLAR?

The FDA product code for VITRO MOLAR is EMA.

Related Clinical Trials

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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Other records listing Dfl Industria E Comercio SA 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.

K123824VITRO FIL LC

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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