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FDA 510(k)

PROVITEMP

K-Number: K122551 · 2013-06-14

ApplicantItena Clinical
Decision Date2013-06-14
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROVITEMP is the device name listed in this FDA 510(k) record. The listed applicant is Itena Clinical. It received FDA 510(k) clearance on 2013-06-14 under 510(k) number K122551. 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 PROVITEMP?

PROVITEMP is a medical device that received FDA 510(k) clearance on 2013-06-14. The listed applicant is Itena Clinical. The 510(k) number is K122551.

When did PROVITEMP receive FDA 510(k) clearance?

PROVITEMP received FDA 510(k) clearance on 2013-06-14, under 510(k) number K122551.

Who is the listed applicant for PROVITEMP?

The FDA 510(k) record lists Itena Clinical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROVITEMP?

The FDA product code for PROVITEMP is EMA.

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Other records listing Itena Clinical 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.

K170207ObturysK162960TotalC-RamK122521PREVENT SEALK122549DENTO TEMPK121804PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEMK122522DENTOETCH QUICKBOND BOND ACTIVATOR

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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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