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FDA 510(k)

HOFFMANN'S CEMENT (PHOSPHATE, NORMAL)

K-Number: K123273 · 2012-12-07

ApplicantTemrex Corp.
Decision Date2012-12-07
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HOFFMANN'S CEMENT (PHOSPHATE, NORMAL) is the device name listed in this FDA 510(k) record. The listed applicant is Temrex Corp.. It received FDA 510(k) clearance on 2012-12-07 under 510(k) number K123273. 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 HOFFMANN'S CEMENT (PHOSPHATE, NORMAL)?

HOFFMANN'S CEMENT (PHOSPHATE, NORMAL) is a medical device that received FDA 510(k) clearance on 2012-12-07. The listed applicant is Temrex Corp.. The 510(k) number is K123273.

When did HOFFMANN'S CEMENT (PHOSPHATE, NORMAL) receive FDA 510(k) clearance?

HOFFMANN'S CEMENT (PHOSPHATE, NORMAL) received FDA 510(k) clearance on 2012-12-07, under 510(k) number K123273.

Who is the listed applicant for HOFFMANN'S CEMENT (PHOSPHATE, NORMAL)?

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

What is the FDA product code for HOFFMANN'S CEMENT (PHOSPHATE, NORMAL)?

The FDA product code for HOFFMANN'S CEMENT (PHOSPHATE, NORMAL) is EMA.

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Other records listing Temrex Corp. 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.

K851030TEMREX-DENTIN VARNISH

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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