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FDA 510(k)

ULTRACEM

K-Number: K132255 · 2013-10-24

ApplicantUltradent Products Inc. / Oratech, LLC
Decision Date2013-10-24
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ULTRACEM is the device name listed in this FDA 510(k) record. The listed applicant is Ultradent Products Inc. / Oratech, LLC. It received FDA 510(k) clearance on 2013-10-24 under 510(k) number K132255. 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 ULTRACEM?

ULTRACEM is a medical device that received FDA 510(k) clearance on 2013-10-24. The listed applicant is Ultradent Products Inc. / Oratech, LLC. The 510(k) number is K132255.

When did ULTRACEM receive FDA 510(k) clearance?

ULTRACEM received FDA 510(k) clearance on 2013-10-24, under 510(k) number K132255.

Who is the listed applicant for ULTRACEM?

The FDA 510(k) record lists Ultradent Products Inc. / Oratech, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRACEM?

The FDA product code for ULTRACEM 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 Ultradent Products Inc. / Oratech, LLC 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.

K132109ENAMELAST

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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