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FDA 510(k)

SYSTEMP.CEM

K-Number: K042847 · 2004-12-17

ApplicantIvoclar Vivadent, Inc.
Decision Date2004-12-17
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SYSTEMP.CEM is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar Vivadent, Inc.. It received FDA 510(k) clearance on 2004-12-17 under 510(k) number K042847. 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 SYSTEMP.CEM?

SYSTEMP.CEM is a medical device that received FDA 510(k) clearance on 2004-12-17. The listed applicant is Ivoclar Vivadent, Inc.. The 510(k) number is K042847.

When did SYSTEMP.CEM receive FDA 510(k) clearance?

SYSTEMP.CEM received FDA 510(k) clearance on 2004-12-17, under 510(k) number K042847.

Who is the listed applicant for SYSTEMP.CEM?

The FDA 510(k) record lists Ivoclar Vivadent, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYSTEMP.CEM?

The FDA product code for SYSTEMP.CEM is EMA.

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Other records listing Ivoclar Vivadent, Inc. as applicant

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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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