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FDA 510(k)

KETAC CEM U

K-Number: K002793 · 2000-09-26

ApplicantEspe Dental AG
Decision Date2000-09-26
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KETAC CEM U is the device name listed in this FDA 510(k) record. The listed applicant is Espe Dental AG. It received FDA 510(k) clearance on 2000-09-26 under 510(k) number K002793. 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 KETAC CEM U?

KETAC CEM U is a medical device that received FDA 510(k) clearance on 2000-09-26. The listed applicant is Espe Dental AG. The 510(k) number is K002793.

When did KETAC CEM U receive FDA 510(k) clearance?

KETAC CEM U received FDA 510(k) clearance on 2000-09-26, under 510(k) number K002793.

Who is the listed applicant for KETAC CEM U?

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

What is the FDA product code for KETAC CEM U?

The FDA product code for KETAC CEM U is EMA.

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Other records listing Espe Dental AG 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.

K011394LAVA FRAME, LAVA FRAME SHADE, LAVA CERAMK011154ELIPAR FREELIGHTK002364PROTEMP HK001494MODIFICATION TO PROMPT L-POPK000595DIMENSION PENTA LK000588DIMENSION GARANT L, DIMENSION GARANT L QUICK

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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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