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FDA 510(k)

CERCOM CEMENT

K-Number: K083398 · 2009-01-26

ApplicantDenali R&D Corporation
Decision Date2009-01-26
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CERCOM CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Denali R&D Corporation. It received FDA 510(k) clearance on 2009-01-26 under 510(k) number K083398. 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 CERCOM CEMENT?

CERCOM CEMENT is a medical device that received FDA 510(k) clearance on 2009-01-26. The listed applicant is Denali R&D Corporation. The 510(k) number is K083398.

When did CERCOM CEMENT receive FDA 510(k) clearance?

CERCOM CEMENT received FDA 510(k) clearance on 2009-01-26, under 510(k) number K083398.

Who is the listed applicant for CERCOM CEMENT?

The FDA 510(k) record lists Denali R&D Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CERCOM CEMENT?

The FDA product code for CERCOM CEMENT 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 Denali R&D Corporation 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.

K083473CLEAR BRAVO

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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