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FDA 510(k)

VITRO FIL LC

K-Number: K123824 · 2013-02-21

ApplicantDfl Industria E Comercio SA
Decision Date2013-02-21
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VITRO FIL LC 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 2013-02-21 under 510(k) number K123824. 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 FIL LC?

VITRO FIL LC is a medical device that received FDA 510(k) clearance on 2013-02-21. The listed applicant is Dfl Industria E Comercio SA. The 510(k) number is K123824.

When did VITRO FIL LC receive FDA 510(k) clearance?

VITRO FIL LC received FDA 510(k) clearance on 2013-02-21, under 510(k) number K123824.

Who is the listed applicant for VITRO FIL LC?

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 FIL LC?

The FDA product code for VITRO FIL LC is EMA.

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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.

K123826VITRO MOLAR

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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